CA1184121A - Treatment of acne and perioral dermatitis as well as for skin infected with a herpesvirus - Google Patents
Treatment of acne and perioral dermatitis as well as for skin infected with a herpesvirusInfo
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- CA1184121A CA1184121A CA000414315A CA414315A CA1184121A CA 1184121 A CA1184121 A CA 1184121A CA 000414315 A CA000414315 A CA 000414315A CA 414315 A CA414315 A CA 414315A CA 1184121 A CA1184121 A CA 1184121A
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- triacontanol
- hydrophilic ointment
- acne
- dermatitis
- treatment
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Abstract
ABSTRACT OF THE DISCLOSURE
A treatment for disorders caused by Herpesviruses, such as herpes simplex, eczema and shingles, as well as for acne and perioral dermatitis. The treatment includes the topical application of an ointment base containing a small quantity of triacontanol. The triacontanol-ointment preparation is applied directly to the infected skin area as often as is needed.
A treatment for disorders caused by Herpesviruses, such as herpes simplex, eczema and shingles, as well as for acne and perioral dermatitis. The treatment includes the topical application of an ointment base containing a small quantity of triacontanol. The triacontanol-ointment preparation is applied directly to the infected skin area as often as is needed.
Description
TREATMENT OF ACNE AND PERIOP~L DERMATITIS AS
WELL AS FOR SKIN INFECTED WITH A HERPESVIRUS
Bac~ground 1. Field of the Ihvention The present invention relates to a method and composi-tion for treating skin infected with a Herpesvirus, and more particularly, to a method and composition for treating skin infected with a Herpes~irus wherein an ointment is topically applied to the skin area infected. It also relates to a method and composition for treating acne and perioral derma titi~, and more particularly, to a method and composition for treating acne and perioral dermatitis wherein an ointment is topically applied to the skin area infected.
WELL AS FOR SKIN INFECTED WITH A HERPESVIRUS
Bac~ground 1. Field of the Ihvention The present invention relates to a method and composi-tion for treating skin infected with a Herpesvirus, and more particularly, to a method and composition for treating skin infected with a Herpes~irus wherein an ointment is topically applied to the skin area infected. It also relates to a method and composition for treating acne and perioral derma titi~, and more particularly, to a method and composition for treating acne and perioral dermatitis wherein an ointment is topically applied to the skin area infected.
2. The Prior Art Herpesviruses come in 70 different varieties, but only a few are infectious to humans~ The viruses infections to humans include ~erpesvirus hominis, which causes herpes simplex; Herpesvirus varicellae, which causes varicella (chicken pox) and zoster (shingles); the Eps~ein-Barr virus~
which causes mononucleosis; and cytomegalovirus, which causes fetal infec~ions. Herpesviruses are also often responsible for fevers, hepatitis, and pneumonia-like illnesses in children and adults, especially those with lowered resistance.
Additionally, eczema is caused by Herpesvirus hominis or Po~virus officinalis, and perhaps other viruses such as Coxsackievirus.
~. HerPes Simplex Of all the Herpesviruses, the efects of Herpesvirus hominis are by far the most c~mmonly experienced.
Herpe~virus hominis, which is responsible for herpes si~plex, has two diff~r~nt f~r~s: ~ype I and Type II.
Typ~ I cau~es Herpes labialis (or21 herpes) in the form of cold sores and unsi~htly lesions around the lips or nose.
Type II causes Herpes genitalis (genital herpes) ~n the form of s~res that appear be}ow the waist, primarily in the genital area. The two types vary little wi~h respect to the nature of their behavior snd either one can take the other's place. Thus, Type II can cause a cold sore while Type I can also infect the genitals. Nevertheless, : Type II is responsible for a~ least sbout eighty percent - (80Z) of genital herpes.
Both Types I and II can be transmitted by sexual as well as non-se~ual contac~; ho~ever, ge~ital herpes is generslly tra~smitted through sexual intercourse. A Typ~
I infection of the genitals or a Type II infection o~ the mouth can occur through oral-genital contact. ~ cold sore virus ~ay be transmitted when two persons kiss or by means as simple as the us~ of the same towel to wipe their faceg.
The eyes can be infected si~ply by rubbing them after touching an infected 8roA. Thus9 th~r~ ar2 ~ variety of ways in which herpes silsple~c viruses I and lI can be transmit~ed. ISoreover, although not the usual case, 'cransmission of the viruses s:an eYen occur before the ~ymptoms of herpes si~plex appear or before ~he inf~ked 5 person is swar~ that he or she has herpes ~imple~
The symptoms of herpes simplex infectlons include the de~.relopment of a cluster of t~ny bumps or blisters, ~ome~imes precedl!d or ~ccompanied by a ~ever or swollen ly~nph glands. The blisters then crust over, and the soses 10 dlsappear--usually within three weeks after the irst YyE~pto~s. However, the V~U5 remains in ~he body ior a lifetilme ~ hibernating in such places as the ~alivary ~lands ~ the nerve tissue, and the lymph nodes . A~ter recovery from the first attack, subsequent infection~ ~nay 15 occur ove~ the ne3~'c few years ~ until gradually the frequency o~ attacks diD~inishes. I:)ccasioslally, however, recurrences may appear over the rest o~ the individual's life~ The reappearance of herpes infections is then often tri gesed by ~tress, ~ati~ue ~ exposure ts~ sun, ~crauma, 20 feYer, or menstruation~
~ , . . .. . . . . . .
Other complications may develop in those who are afflicted with a herpes simple~ v~rus. If a person sufferirlg from herpes simplex touches a sore or blister and then rubs his ~yes, he may develop a serious eye 5 in~ection known as herp~s keratitis. Thousands of Americans annually lose their sight because oX this disea~e .
F~r women, genital herpes simplex carries sp~cial ri8ks. To beeirl with, genital herpes simplex has been linXed 'co cancer of the cer-vix. Female herpes victims are five co ~ev~n times mor~ likely to develop cervical cancer ~han slon-infec~ed females. I;enital herpes simpïex can also cause serious bisth defects. ~ pregnant woman with an actiYe genltal herpes simple:~ ~nfection faces a fifty 15 percent (50%) chance of pas~ing the diseas~ to her baby as the child passe~ throu~h the birth canal. ~bOue f~ty pereent (50%) o~ th~ new~orn inf~nts wh~ dev~lop herpes ~impl~ die o~ the in$~ct~on; ~eventy-five percent (75%) o$ tho~e who survive suffer from blindness or brain damage. Fortunately9 if ~ores are ~ou~d clo~e to ~he time of delivery~ the doc~or ca~ p~rfor~ Caesarean-section tn prevent infection of the ~ewborn as i~ pas~e~ through the ~irth canal.
Most Amerioans hav~ been expo~ed to th~ herpes simplex virus; indeed, ei~h~y peroent (80'~ of the ~merican population carr~ he herpe~ ~implex virus, and --5~
an~ibodies against the virus hav~ been found in up to ninety-fi~e percent (95%) of blood samples tested.
Although some people never experience ~ymptoms, (possibly b csuse their immune systems repulse the virus so it cannot sustain its attack), abou~ ~even out of eight pcople who come in se~ual contact with the herpes s~mplex virus.will contract an inection. It is estimated that fro~ thirty (30) to seventy (70) million Americans suffer ~ccasionally from ~he ~ost comm~n form of herpes simplex infection, that of coldsores. Moreover, it is estimated that from five (5) to twenty ~20) ~illion Americans ~uffer ~rom ~nital herpes simplex, and ~hat each yeas, half a ~illion more Americans ~oin these ranks.
Since there has pseviously e~isted no known effectiv~ tre~t~nt for herpes si~plex, the total number of perso~s inflicted with herpes ~i~plex continues to increa~e. Sc~entists have tried ant re~ected ~any dif~erent ~reatments or herpes such as vitamin C, zinc9 e~her9 and ice packs. It i~ eYitent ~a~ in the absence of a treatment for herpes simplex, this relatively new Yenereal disease esuld potentially reach epidemic propor~ions.
B. Eczema Another Herpesvirus disorder which plagues many people is atopic eczema. Eczema occurs in primarily three forms (1~ the infan~cile form, (2) the adult form, and 5 (3) the localized ~orm.
The infantile form of eczema ~ay first appear soon after birth, oft . n by the fouroch rnonth of the infant ' s life. Infantile eczema is generally manifested as pr~ce~s~s which n~ay be red, dry, slightly ~caly, cracked, 10 and excoriated, or sometimes moist and oozing. Infantile ecæema is most ~requently manifested around the face, scalp, n~clc, and diaper areas. û}der children and young adul~s g~rlerally experi~nce ~nanifestation of the disease in the flexural areas and the cheeks~ fewer than half 15 oX the individuals inflicted with infantile eczema, th~
dis~ase clear~ up by che age of ~our, yet even in these individuals, the disease may occur at a later age. The majori~cy o~ eczema victims ~till experienc~ occasional ~lar~ ups through the young adult yes~s, up ur~til about 2Q the age Qf thirty, ~t which ~ime the disease usually disapp~ar~ .
The adult orm of ecze~a is generally manifested in the antecubital and popliteal areas, and i~ ~ome rases around the hands, feet, and face. The infected ~kin is ~enerally dry 9 erythematous, and excoriatet with bacterial crusting and redness.
The localized form of eczema, which occurs in diverse individuals 9 iS pri~arily ~anifested around the wrists, ankles, hands, feet and ear~, as well as the perianal, perivulvar, and scrotal regions.
~y far the worst consequence of atopic eczema is the pruritis or itching which is associated with this disease. Those inflictet with atcpic eczema often find pruritis to be a life-long companion. Any relief to be had from such intolerable i~ching is gratifying to say the 15 lease. There are many ~actors which play a role in the occurrence of atopic eczema, such as dietetic and emo'cional factors. Moreover, seasonal fluctuation~ arP
a~ important factor with ~topic eczema g2nerally becoming worse during the winter season.
One of the greate~t fears of those who are inflicted with atopic eczema, ~s that these individuals are generally more suscep~cible to ~iral infectiorl, and in particular, ~o infestation by a herpes simple7c ~irus or a ~raccinia virus. Additionally, ~chose sufferinE~ fron~
a~opic eczema are abnosm~lly ~usceptibl~ to er~vironmerltal irriltants,. Consequently, tho~e inflicted wi~h 'che disease are of~n advised to wear clothislg which is soft and light9 So ~t~y away from heat gources; to take brief baths or showers not e~ceeding five ~inutes and using a ~inimal aMount of soap; to avoid primary irri~ants such as paints, cleansers, solvents, ohemical sprays, dusts, and the like; and som~time~ to change their residence to a wan~, dry temperate, unvarying cli~ate where temperature e~tremes are rarely experienced.
Although there is ao Xnown cure for atopic eczema9 ther~ are various helpfu~ treatments which all have one goal in oommo~: ~o stop the intolerable itching that accompanies atopic eczema. Examples of these treatments include antiseptics, for e~ample antibacteral cleansers such as Betadine ~a registered trademark ownet by Purdue Frederick Co.; Norwalk, Connecticut 06856) a~t Hibitaine;
topical glucocorticoid creams; sys~emic glucocor~icoids;
antipruritic agents; and an~ibiotics. Although the atopic and systemic glucocorticoid trea~ments have proven ~ost effective in treating long-continued atopio ecze~a, adverse topical and systemie efects are often experienced when such treatments are used. Co~sequently, adverse effects in those undergoing glucocorticoid traatments must be carefully monitoret.
It would, there$ore~ be estre~ely desirable to provide an effective tseatme~t for various disord~rs caused by the Herpesviruse~ especially herpcs simplex.
~oreov~r t it would be desirable to provide an improved treatment for Herpesvirus disord~rs such as ecze~a, which i~ safe, having no kno~n ~9id~ effects ~ ~ny body locations. Such treatments are describet and claimed herein.
C. Acne A common skin disorder which plagues nearly all adolescents at scme time or snother is that of acne vulgasis (comm~nly referred to as "acne"). The peak incidence o acne occurs at about ~ourteen (14) years of age in girls and sixteen (16) years of age in boys9 with the ~ost severe cases in boys tending to occur e~en later.
Although ac~e has generally been considered a teenage problem, it is a disease for those wh~ are in their ~wenties and thirties as well. There are few diseases which p~oduce more psychic trauma9 malad3us~ment, insecurity, and ~eelings of inferiority than does acne.
The cause~ and factors influencing the development of ~cne are many, and generally nnt well unders~aod. Acne is n~rmally manifestet in a variety of lesions, including comedomes, papules, pustules, cy~ts, and æcaTs. These 4~
lesions occur in the s~in areas ha~ing the greatest concen~ratinn of sebaceous glands, ~., the face, central chest, ~nd ~pper back. In severely affec~ed subjects, lesions may also appear on the arms, back cf the necX, lower bacX, buttocks, and thighs.
I~ some adolescents, acne is ~anifested by nothing ~ose than a ~ew ~czttered pustule~ and oomedomes that have a relatively short duration and produce no permanent affeets. Other ad~lescents, on the other hand, develop more extensiYe acne that not only persists, but also produces per~anent pits and scars. The lesions which are generally responsible ~or the scars are the tender, red pustu~es and cysts. Some surveys indicate that over two percent (2%) of all high school ~tudents have a severe ~orm of acne.
Many differen~ treatments for aone have been developed over ~he years; however9 the effectiveness of known treatments with respeet to relatively diffi~ult acne problems has been rather limited. For mild cases of acne, regular shampooing of the scalp and dai~y use of sn abrasive ~cap on the acne-~nfected skin are typical of recommended tre~t~ents.
~ os treating ~oderate cases of Acne, preparations for dsying and peeli~g the skin area ~ubject to coDedomes, papules, and pustules are ~fgen recommended. ~ome typical preparations for the treatment of moderate arne include a powder-base ~hake l~tion containisll; re~orcinol and sulfur;
---ll--benzoyl pero~cide; topical ~ntibiotics ~uch as erythromycin and clinda-nycin; oral antibiotic~ such as tetrscycline;
retinoio acid (vitamin A acid); as well as modera~ce irradiation wi~ch ultraviolet light.
For treating n~ore severe cases of acne where pustular and cystic lesions cause scarring, a ~cotally safe treatment has preYiously not been found. Some preparations which have been used to treat severe cases of acne include those containing antibiotics, Kluc~corticoids~ or hor~ones. Many ~ystemic antibi~tics carry undesirable or unwarranted side effects snd risks, thus restricting the use o antibiotics ~o those which are ~ild and relRtively safe, such as erythromycin and tetracycline. ~ndesirable side effects and risks are also experien~ed fsom the use of glucocorticoids and h~rmones.
F3r example, æome ide effects from estrogen-pro~esten medications (a typical hor~one treatment) include thromboembolic disease, ~allbladder disease, strokes, myocardial infarcts 9 hepatic tumors, hypertension, and endometrial cancer. Moreover, the oral ingestion or topical application of ~he female hormcne estro~en by males may result i~ other undesirable side effeo~s 9 such as the emergence of femini~e characteris~ics.
Additi~nally, antiandro~ens, ultraviolet ~ight, 25 cryotherapy using 301id oarb3n dio~id~ or liquid nitrogen, minor ~urgery, chemosurgery, and eYen ~- ray therapy have ~en used in the trea~cl22nt o~ ~evere caæes of aorae. ~s wi~h the other prçparati~ns OT treat~e~ts, certain risks or undesirable consequences are i~herent in each o these treatment~ as well. One imp~rtant undesirable charact~ristic of most all of the prior ar~ acne tre~tments 5 i~ tha~ ~he effects of these ~reatm~nts are often felt throughout the body, not just the localized skin area re~uiring treat~ent.
D. Perioral Dermatitis ~no~her relative~y comm~n skin disorder is perioral denmatitis. PeriDral dermatitis, which primarily plagues young adult women, is less co~mon among ~en and cccurs ~ccagionally in young children. This disorder is usually manifested 8S a localized grouping of red papules, vesioopapules, and papulopustules around t~e lip~, ~outh, chin; paranasal area, and even the ~pper eyelids. Perioral ter~atitis lesions often burn, and exaoerbations and se~issions are frequent. Moreover, the lesions associated with perioral der~atitis generally worsen with pregnancy and menstruation. Othes ~sctors which ag~re~ate perioral 2Q dermatitis lesions inciude heat and perspirati~n.
Generally9 aft~r th~ee ~o ~ix ~onth~ from on~et, the lesions finally disappear.
Perioral denmatitis has proven to be resistent to ~os~ therapy, althou~h ~ome treatments have been found to be ~mewhat beneicial. Som2 of these treatment~ include ~1) tetracycline; (2~ a lZ hydr~cortisone preparati~; (3) the avoidance ~f all cosmetics, e~cept f~r lipstic~ and ~34~
-13-.
~ascara; and (4) dail~ cleansi~g with soap. The long-~onti~ued use o~ po~ent topical glucDcorticoids has been known to protuce the adverse effects ~f perioral der~atitis. Therefore, glucocorticoid treatments which are used to treat perioral dermatitis lesions fflUSt be limitot in strength, or the di~order can be se~erely complicated.
It would, therefsre, be a ~igni~icant advancemen~ in the field of dermatol~y to provide a ~ore effe~tive treatment for acne, a~d ~specially for extremely se~ere cases of acne, which is safe, having n~ known side effects in any body locations. Additionally, it would be another significant advancement tG provide an effective treat~ent for perioral dermatitis, and especially a treatment which woult avoid the adverse effects o~ treatments such as glucocorticoid treatments. Such treatments are dPscribed and clai~ed herein.
Brief 5ummary snd Ob~ects of the In~ention The pres~nt invention relates to a treatment for various types of disorder~ cau~ed by ~erpesvisuses, and ~ost importa~tly, to a treatment for herpes simplex and eczema. This nov~l combinatio~ he~pes simplex ant eczema treatment compri~es applying a preparation to the ~nfected skin area; the preparation comprising ~ carrier 25 ~dicant (such a~ hydrophilic ointmen~) to which is added a small amount of triacontanol. This prepara~ion may be periodically appl~ed to the infected ~kin area as n~eded.
-The activ~ ingredient in the preparation, triacontanol, has proven to be safe and has no known side effects anywhere in the body.
It is, therePore, an object of the present invention to provide an effective treatmen~ ~or disorder-~ caused by a Herpesviru~, and most especially, for herpes simplex, eczema and shingles.
A further ob~ct of the present invention is to provide a ~opical treat~ent for disorders caus~d by a Herpesvirus in which only the in~ected skin area is exposed to the ~edicant treat~ent.
The present invention also relates ~o an improved acne treatment which is effective even for extremely ~evere ca~es o~ acne. MoreDver, the present invention 2elates to an e~fective tr~atment for pesioral dermatitis. This novel combination acne and perioral de~m~ treatment coMprises applying a preparation t~ th~ infected skin : area; the prepar~tion comprising a carraer medicant (such a~ hydroph~l~c ointment) to whioh i~ added a small a~ount of triacontanol. Thi~ preparation ~ay ~e periodically appli~d to the infected skin area a~ needed. The ac~ive i~gredient in the prepar~kion, triacontanol, has proven to be safe and has no known side effects anywhere in the body.
It is, therefore, ~n obJect of the present i~vention to prov~de an improv~d acne treat~ent which is safe, and effecti~e a~ainst even severe cases of acne.
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Another object of the pre~ent is~vention is to pr4vide an effective treatlDent ~r peri~ral dermatitis.
A further object o~ the present invention is to provide a ~copical treatment for acne and perioral 5 derma~i~cis in which only ~he infected ~kin area is exposed to the medicant trea~men2:.
These and other ob~ect$ o the present inv ntion will become mo~.e fully appasen~ in view of the followinE
detailed description and appended clain3s.
Detailed D~scription o the _eerred i:mbodiment The present invention relates to a method and composition for treating skin infected with a Herpesvirus. Each of the treatments for the variou~ types of ~Ierpes~7irus disorders ~ e . ~ ., herpe~ simple:~ , eczema and shingles ) is ~ubQ~antially ehe same, ant includes the topical application o a preparation comF~rising a carrie-:
medican~c containing a smalï amount of triacon~anol. The triacontanol preparation Dlay be applied periodically to an infected skin area as needed. Indeed, clinical experiments indicste that the preparation may be applied several times daily with~ut identifiable side effects.
Consequerltly 7 the preparation ~ay be applied whenever rleeded to all~ria~e di~comfor~c or t~ clear up lesions.
Shortly after applica~ian o~ the pr~paraticn 'co 8 herpes 25 simple~ lesion, the pain arld itching associated with herpes simplex disappear. Repea~ced application causes the herpes simpleac lesion itself ~o disappeas l often within a few day~.
The present invention also relates to a method and COM-position for treating acne and for treating perioral derma~
titis. Each of these treatments is substantially the same, and includes the topical application of a preparation S comprisi~g a carrier ~edicant ~ontai~ing a small amount of triacontan~l. The triacontanol preparation may be applied periodicaily to an infected skin area as needed. Indeed, elinical e~periments indicate that the preparation may be applied ~everal times daily with~ut identi~i~ble ~ide ~ eff~cts. Cons~quently, the preparation ~ay be applied whenever needed to alleviate discomfort or to clear up lesi3~s.
The active ~ngredient in ~h~ preparation is triacon~anol. Triacon~anol, slso known as melissyl alcohol, myricyl a}cohol, or hydsoxytriacontane, is a strai~h~-chain~ aliphatic, thirty carbon waxy alcshol hsvi~g the formula 3(~H2)~H20H- Al~hough triacontanol has been found usefu~ for such pu~po~es as the f~ti~ization of rops, to the inventor's knowledge$
triacontanol has n~t been used as the active ingredient in ny medicsl treatment.
~5 ., .. ., . ~ .. " . . . .. . . .
Experimental ~pplica~ion of tr~acontanol to skin inected with acne or a Herp~svinYs shows that triacontanol ha3 the following advantsgeous qualities: -~1) it remov~s pain and l~ching; t2) $t clears up lesions 5 sss~ciat~d with Herpesviruses s~ch as herpes ~implex lesion~; (3) iS is anti-infla~4ato2y; (4) it res~ores lipid levels on the skin to normal levels (imp~rtant with respect to Herpass7irus disorders ~uch as ~czema); (5) it i5 virus and bacteria static; and ~6) it is safe and has no 10 knowrl side ef~ct~ ~n arly body locat$ons.
Experimental ~pplicati~n ~f triacontanol ~o skin infected with acne or perioral dermatitis ~hows that ~criacontanol has the followin~ advantag~Gus qualities:
(1) it rem~ves pain and i~cching; (2~ ît clears up acne 15 lesions and perioral dermatitis lesions; (3 ) i~c is anti-in~lamma~cory; (4) it rest~res lipid levels on che skin ~co nDrmal levels; (5~ i~c is virus and bacteria s~atic; and (6) it is safe a~d has no Icnown side effects in any body 1 Q cat ions .
~o The triacontanol preparation ls psepared by simply ~ixing a very s~all qua~tity of triacontanol, about one hundredth of one per~ent (O.OlX~ by weight, with a medlcant base u~til thoroughly blended. Although 0.01%
~riacontanol ha~ bee~ found sufici~n~ for effeo~ive 25 tseatment, qu~ntities much s~ ller than ~his are also llkely ~o provide effect~e treat~nt~
An important cons~deaation in the preparation is the choice of an appropriate medicant base. The selected m~dicant base must be co~npatible with the triacontanol so as to Tllai~cain it in active form for effective 5 applical:ion. One oiTltmerlt which has beer~ employed in the present triacontanol invention i~ a standard VSP
hydrophilic ~intment; a thousand gram~ of which con~ains the following compoun~ ~n the indicated amounts:
Hydrophili c Oint~er~ t - USP
ComPound Amount Methylparab~n 0 . 25g.
Propylparaben 0. 15g.
Sodium l~uryl sulfate 10g.
Propylene glycol 120~.
S'cearyl alcohol 250g.
Whi'se petrolatum 250g.
Purified water 370g.
The ingredients of hydrophilic ointment IJSP, which ointment is commonly as~ailable from a variety of cofnmercial 20 sources, are combined as follows. First, the stearyl alcohol and the white petrola'cum are melted on a steam bath snd warmed to about 75C. The other ingredients axe dissolved ~n th@ purified water snd are also warmed ~e~ about 75C. .A11 ingredients are then D~ixed together and stirred until the 25 mixture cclngeals.
, --lg--It will be understood that the hydrophilic ointment discl~sed above is given by way of example only, and ~hat nu~erous other carrier medicants may also be suitable, such as an oleic acid ointment base. ARain, it i~ the triacontanol, not the carrier medicant, which is the active ingredient in the preparation, the carrier ~edicant merely acting as a carrier for the triacontanol to pxo~ide for the ~ffectiv~ ~pplication of the triacontanol in active form to ehe ~kin. Thus, it will be appreciated that one of ehe most importa~t properties of the carrier medicant is its abiliey to provide ~ufficient contact ~etween the active triacontanol and the skin to effectively treat the skin.
The above-described triacontanol-hydrophilic ointment preparatio~ has been found to be efective in the treatment of disorder~ caused by Herpes~iruses, such as herpcs simple~, eczema, and zoster ~shingles). I~ particular, the preparation has esp~cially been found to be ef~ectiv~
a2ain~t herpe~ simpl~ and eczema. Moreover, the ab~ve-d~scribed triacontanol-hydrophilic ointment preparation has been f~und t~ be ef~ective in the treatment of acne ~nd perioral dermatltis, which is ~omewhat related ~
acne. Experimentally, the best results have been obtained in using the preparation in ehe treatment of perioral ti~is. 5 Experimentally, the best results have been obtained in using the preparation in the treatment of herpes simplex (all types of lesio~s, particularly cold sores) and eczema.
Although the effect of the triacontanol preparativn on other Herpesvirus di~orders such as chicken pox, mononucleosis, fetal infections, fevers, hepatitls, and pneumonia-like illnesses is yet unknown, it i~ well-anticipated that the prepara~ion ~ay al~o be effec~iv~ in the treatment o$ these discrders.
10~ver twenty patients with herpes simple~ lesions in the form of cold sores have been treated with the above-described ~riacontanol-hytrophilic oint~ent preparstion. Upon topiral applicat~on of the preparation, these patients typiGally ount that the itchin~ s8~0ciated with the herpes 15~imple~ lesion3 disa~peared after about 30 to 60 seconds and that the pai~ also di~appeared ~fter about four to eight : ~inutes. The effectiveness of the preparstion in aiding the healing proce~ was found to vary w~th the age o~ the lesio~.
Typically, it was ~ound that if a lesion was treated within four hours sfter its initial ~ppearance, the lesion disappeared completely witbin only a few hours--commonly within about si~ hours. For older lesions, it was found that treatment caused the lesions tn disappear in about one tG
s~ven days~ generally seducing the normal life of the lesion ~y at least fifty perce~t (50%3. Overall, the triacontanol-hydrophilic ointment preparation deorea~ed the normal healing time for herpes simplex lesions by up to eighty percent t80%) or ~ore.
About 25 patients with atopic eczema were also been treated with the above-described triacl~ntaYlol-hydrophilie oint~ent prepaa ation. The a~verage patient ~reated had experienced the symptoms of atopic eczema for at least ten 5 years and had suffered from the sy7npt~ms of atopio eczema durinE~ at least for~y percent (40~ of ~he previous year.
Thes~ patien~s found that their eczema lesions, which wer~
four weeks old on ~he average, were comple~cely healed fi~e days after begiD~ing treatmesl~c wi~h the triacon~anol-10 hydrophilic ointment pr~paration. Thi~ is ir contrast to the three-week healin~ period which i~ generally required when the well-Xnown corti~one crea~ treatments were used.
Moreov~r9 the seYere itchinE a~socis~et with the eczema lesions disappeared within two hours after application of 15 the triacontanol~hydophilic ointment preparat~on, whereas the cc~rtis~ne rrean~s requirecl about two weeks to di~pell ~che ltohing. Additionall3~ t the pain and sores~es~ associated with th2 lesions commonly disappear2d within only a few minutes ster application o th2 triacontanol-hydophilic 2~ oint~ent p~eparation, a~ opposed to about five days for the cortisone ~ream~. ~inally, the triacontanol-hydrophilic oint~ent preparation decreased thQ normal healing time for t~e lesions dra~atically.
Clinical studies were conduct~d on about ~ifteen patients who8 on the average, had experienced perioral derma~i~is over a period ~f at leas~ three years, and had experienced manifes~ati~ns of the disDrder at least twice a year. Nor~ally, ~hree ~o 5iX months were required to heal the perioral de~matitis lesions of the~e pstients. After treatment ~ith the triacontanol-hydrophilie ointment preparation o~ the present i~vention, the time required for healing wa~ decreased dramatica~ly. Moreover, the itching ~s~ociated with perioral dermatitis typically disappeared within only a few secsnd~ aft~r application of the triacontanol-hydrophilic oin~ent preparation to the lcsions.
One of the significa~t advantages of usin~ triarontanol ~s the active in~redient in the treatment of the present invention is that triacontanol has prove~ itself to be safe.
Indeed, it occurs naturally in al~al~a, honey, an~ in the waxy portions of several edible plants. Reeently, it was found that triacon~anol dramatically increases croy yields when used as a fertilizer. A group at Michigan State University discovered that when as little as five milligrams sf triacontanol we~e mixet with 30 to 4Q gallons of water in the treatme~t of one acre of crops 9 grow~h was increased by an av~rage of 12 percent. Since triacontanol is a common plant constituent, it ~ not unusua~ for on~ to co~sume enough tri~con~a~ol in on~ ~eal to treat at leas~ an acre oP
crops .
~ nc~her indication ~ha~ triacontanol is safe is ~che fact that it is fousld naturally ~n beeswa~ ~8 ~ p~lmitate e~'cer a2ld possibly, in e~ctremely s~all amoualt~, as the ~imple alcohol itself. Beeswa~c has be2n used for many years as a 5 stifeninl2 agent in many phaxmaceutical preparations such as eerates, oint~ents, pastes, and petroxolins. Cerates are ~os'cly usetl ~s dressings for in1amed ~kin ~urfaces and s:oT~tain suf~icient b~eswa~ co give them a desired co~siste~cy. Moreover, many cosmeti~ prepasations such as 10 all-purpose creams, night cIeams, vanishing creams, lotions, ~ascaras, lipsticks, cream lip rougQ, and face and body makeup contain significant amounts o beeswax. Thus, the long-time use of beeswax-containing preparations may proYide a basis for the belief that ~riacontanol is safe when applied 15 topically.
Althou~h found in many preparations presently on the market, ilt is uncl~ar why3 if any triacontaslol is presen'c in ~eeswasc as the free alcohol, it is not 3cti~re a~ainst h~rpes plex and oth~r Herpesvirus ~isord~rs; acne arld per~oral 20 de~atitis. First of ~ c~ present ~n becswax ~s th~ palmita~e, it is thought that triacont rlol i~
not ~LC'ClYc wher~ in kh~ fosm of ~ palmitate ester. Iqoreover, it i~ ~os~ecture~ ~ehat even i~E a very small amount of tria~ontanol is present as a iEree alcohol in 25 bee~wax, perhap~ the amount i5 ~COO 3mall to be ~ffective or perhap~ the enviaor3men'c iR~posed by ~he o'cher constituer~ts of ~eeswax in ~om~ ~y prohibit~ th~ triiacontsnol froal having any ~ffect. This supposed inhibitive effect could be due in part ~o hydrophobic interaction between ~riacontanol molecules in thè beeswax environment. Additionally, the inactiYity of ~y ~riacontanol ln beeswax might also possibly be explalned by the inability of the ~kin to ef~ctively ab~orb any triaconta~ol fro~ th~ beeswax e~visonment. Furthermor~ it ~s al~o pos~iSl~ that very close cont~ct between the triaconta~ol and the monomoleeular cell wall o~ the virus is requiret for effective treatme~t.
Such clos~ conta~t could very well be inhibited by the beeswax environment surrounding any triacontanol which might be present. Whatever th~ reason for the ineffectivenes~ of beeswax ~ treatin~ Herpesvirus di~orders, ~cne ~nd perioral dermat~t~, for purposes o~ the present invention, it will bé appr~ciated that the choice of an appropriate ~arrier ~edicant or ~he triacontanol such as the hytrophilic ointment described hereinabove, is very important.
It wil~ be appreoiated that the invention may be embodied in other specific forms without departing from its spirit or esse~tial characteristics. Th~ foregoing descriptions are to be co~idered in all respects only as illustrative ant not restrictive. The scope of the invention i~, therefor~9 indicated by the appended claims rather tha~
by the foregoing description. ~ll changes which come within the meaning and range of e~uival~ney of the claims are to be mbraeed within thelr ~cope.
SD 25 ~
~ s oriyinallv disclosed, a triacontanol~ointment preparation is applied directly to the infected skin area for treatment for disorders caused by ~erpesviruses such as herpes simplex, eczema and shingles, as well as for acne and pe~ioral dermatitis.
In an additional aspect, the inventlon relates to a method for treating inflamma~ory skin disease and more particularly to a novel method for treating human skin infected with viral infections such as, ~or example, Herpesvirus, but as well as to the treatment of other infections of the skin where inflammation is a problern, By inflammation is mean~ the destruction and repair of the tissues in response to irritation, and the means whereby the irritant is removed.
Such a definition places no limits on the amount of the response or the degree or kind of irritation.
Because irritation by the normal products o~ growing and dying cells is related to the process of intercellular communication that occurs physiologically, inflammation merges with the normal behavior of ~issues. When minimal it may differ only in degree rom the normal physiological process by which tissues control their requirements from their ~lood supply.
Inflammation is necessary for repair as well as for the removal of irritants. However, repair, as in wound healing, differs only quantitatively from those processes which control the normal growth and contour of the tissues.
~ SD 26 ~
S~elling of the tissues is initially due to edema fluid, but in more chronic inflammation white cell infiltration may make a main contribution~ The tissues themselves often increase in sizeO Thus acanthosis and an increase in the papillary vasculature is a usual response of the epidermis and upper dermis to irritation.
A papular lesion following an insect bite may show a considerable increase in the bulk of the tissue which may persist after the initial edema has been resolved.
Pseudo-epithiliomatous hypertrophy is not unusual in uncontrolled inflammation.
Heat is a usual consequence of increased flow of blood through the skin. In acute lesions the skin may be heated as a direct result of local increase in metabolic rate. In chronic inflammation neither local metabolism nor blood flow may be increased, and the skin may feel cold. Heat loss cannot be exactly correlated with redness, because, areas of fast flow may be on the border of a more congested and slow~flowing system.
Thus conduction of heat to the surface of the skin may be considerable over a large, deep arteriovenous fistula while the upper dermis may show all the effects of severe stasis consequent on raised venous pressure.
The sensations that accompany inflammation of the skin include burning, stinging, itching and tenderness, and are thus more varied than in most internal oxgans.
Which of these sensations predominates depends in part on the site, depth, in-tensity and duration of the inflam~
,f' -~
~ ~D 27 ~
matory process~ Thus in urticaria stinging ma~ accompany transient superficial lesions, itching is the usual sensa-tion in papular urticaria or in lesions due to histamine release, while pain and tenderness may accompany deeper lesions of long duration, as in delayed pressure uticaria.
Inflammation is a response to any irritation, and the mechanism applies equally to infection, sunburn, abrasions, contact dermatitis or the various patterns or angiitis seen in dermatological practice. Studies of the effects of injury to the skin show early and delayed phases of the inflammatory response, and these are similar whether induced by trauma such as pressure or by ultraviolet irradiation, or any of the factors listed.
It would be extremely desirable to provide an effective treatment ~or inflammatory skin diseases.
This additional aspect of the invention is based upon the discovery ~hat triacontanol has been found to be an effective agent for treating inflammatory skin diseases infected with viral infections such as Herpes~
virus or other skin diseases such as dermatitis (eczema), contact dermatitis, seborrheic dermatitis~ atopic derma-titis, scaling papular diseases such as psoriasis and the like. The invention will be described in greater detail in conjunction with the treatment o~ Herpesvirus infections such as herpes simplex infections and atopic eczema hut as will appear more ~ully hereinafter the present invention is not limited to these skin diseases as other skin diseases where inflammation is a problem ~ `
~ ~D 28 have been successfully tre~ted with triacontanol~
The no~el anti~inflammatory of the present invention, triacontanol, is preferably used in association with a pharmaceutically acceptable carrier, such as a hydrophilic ointment, designed to be applied topically to human skin infected with viral infections or other skin diseases where inflammakion is a problem.
Thus the present invention relates to a method for treating inflammatory skin disease. Each of the treat-ments for the various types of dermatitis is substantially the same, and includes the topical application of a preparation comprising a suitable pharmaceutically accept-able carrier containing a small amount of triacontanol.
The above-described triacontanol-hydrophilic ointment preparation has been found to be effective in the treat-ment of viral disorders such as dermatitis caused by simplex, eczema, and zoster (shinglesl. ~he preparation has also been found useful in the treatment of other skin diseases such as seborrheic dermatitis, contact dermatitis, atopic dermatitis and psoriasis. Moreover, the triacon-tanol-hydrophilic ointment preparation has been found to be effective against acne and perioral dermatitis~
Experimentally, the best results have been ob-tained in using the preparation in the treatment of herpes simplex ~all types of lesions, particularly cold ~ .
-s, ,~
~ SD 2 sores~ and eczema, ~lthough the effect of the triacon~
tanol preparation on other Herpesvirus disorders such as chicken pox, mononucleosis, ~etal infections, fevers, hepatitis, and pneumonia-like illnesses is yet unknown, it is well-anticipated that the preparation may also be effective in the treatment of these disorders.
Over thirty patients with herpes simplex lesions in the form of cold sores have been treated with the above-described triacontanol-hydrophilic ointment prepara-tion. Upon topical application of the preparation, thesepatients typically found that the itching associated with the herpes simplex lesions disappeared after about 30 to 60 seconds and that the pain also disappeared after about four to eight minutes. The effectiveness of the prepara-tion in aiding the healing process ~as found to vary withthe age of the lesion. Typically, it was found that if a lesion was treated within four hours after its initial appearance, the lesion disappeared completely within only a few hours -- commonly within about six hours. For older lesions, it was found that treatment caused the lesions to disappear in about one to seven days, generally reducing the normal life of the lesion by at least fifty percent (50%). Overall, the triacontanol-hydrophilic ointment preparation decreased the normal healing time ~5 for herpes simplex lesions by up to eighty percent (80%) or more.
Analysis of the data rom thirty subjects indicated that they had herpes simple~ for variabls lengths of time, , -. I
~ ~D 3a ~
from one to 45 years, ~ith a mean of 12 years~ In this group, herpes reoccurred one to 18 times per year with a mean of six times per year.
Triacontanol signîficantly reduced healing time in the 27 cases where healing time was indicated pre~ and post-treatment (:pr. O~Q001). The mean healing time for previous lesions was 10.9 days with a range from 3 to 21 days. The mean healing time after treatment with triacontanol was 4.4 days with a range of 1 to 14 davs.
Twenty-six out of twenty-eight (93%) subjects indicated that triacontanol decreased healing time.
When further asked to quantify how much triacontanol decreased healing time, the mean response was an 80%
decrease.
Forty patients with atopic eczema were also treated with the above-described triacontanol~hydro-philic ointment preparation~ The average patient treated had experienced the symptoms of atopic eczema for at least ten years and had suffered from the symptoms of atopic eczema during at least forty percent (40%~ of the previous year. These patients found that their eczema lesions, which were ~our weeks old on the average, were completely healed five days after beginning treatment with the triacontanol ointment preparation. This is in contrast to the three week healing period which is generally required when the well-known cortisone cream treatments were used.
As shown below treatment for vaxious types of ~ SD 31 ~
disorders caused b~ skin inflammation and most importantly, an anti~inflammatory treatment for the Following diseases as set forth in Tables 1-3 has been successfully used.
T_~le~l .. . .. . ~ ~ ~
V'ral disorders respon5ive to triacontanol Patients Herpes Simplex 30 Shingles 5 \Ta~le~2 Disorders generally responsi-ve to triacontanol Patients 10 Seborrheic dermatitis 34 Eczema ~o Lichen Simplex Chronicus 8 Pruritus ani 3 Psoriasis 12 15 Later phase of contact dermatitis 12 Later phase of irritant dermatitis 20 Xerosis 22 Table 3 Disorders less responsive to -triacontan~l ~Pa*ien~s 20 Lichen planus 2 Dermatitis herpetiformis Lichen schlerosis et atrophicans ~wJ '
which causes mononucleosis; and cytomegalovirus, which causes fetal infec~ions. Herpesviruses are also often responsible for fevers, hepatitis, and pneumonia-like illnesses in children and adults, especially those with lowered resistance.
Additionally, eczema is caused by Herpesvirus hominis or Po~virus officinalis, and perhaps other viruses such as Coxsackievirus.
~. HerPes Simplex Of all the Herpesviruses, the efects of Herpesvirus hominis are by far the most c~mmonly experienced.
Herpe~virus hominis, which is responsible for herpes si~plex, has two diff~r~nt f~r~s: ~ype I and Type II.
Typ~ I cau~es Herpes labialis (or21 herpes) in the form of cold sores and unsi~htly lesions around the lips or nose.
Type II causes Herpes genitalis (genital herpes) ~n the form of s~res that appear be}ow the waist, primarily in the genital area. The two types vary little wi~h respect to the nature of their behavior snd either one can take the other's place. Thus, Type II can cause a cold sore while Type I can also infect the genitals. Nevertheless, : Type II is responsible for a~ least sbout eighty percent - (80Z) of genital herpes.
Both Types I and II can be transmitted by sexual as well as non-se~ual contac~; ho~ever, ge~ital herpes is generslly tra~smitted through sexual intercourse. A Typ~
I infection of the genitals or a Type II infection o~ the mouth can occur through oral-genital contact. ~ cold sore virus ~ay be transmitted when two persons kiss or by means as simple as the us~ of the same towel to wipe their faceg.
The eyes can be infected si~ply by rubbing them after touching an infected 8roA. Thus9 th~r~ ar2 ~ variety of ways in which herpes silsple~c viruses I and lI can be transmit~ed. ISoreover, although not the usual case, 'cransmission of the viruses s:an eYen occur before the ~ymptoms of herpes si~plex appear or before ~he inf~ked 5 person is swar~ that he or she has herpes ~imple~
The symptoms of herpes simplex infectlons include the de~.relopment of a cluster of t~ny bumps or blisters, ~ome~imes precedl!d or ~ccompanied by a ~ever or swollen ly~nph glands. The blisters then crust over, and the soses 10 dlsappear--usually within three weeks after the irst YyE~pto~s. However, the V~U5 remains in ~he body ior a lifetilme ~ hibernating in such places as the ~alivary ~lands ~ the nerve tissue, and the lymph nodes . A~ter recovery from the first attack, subsequent infection~ ~nay 15 occur ove~ the ne3~'c few years ~ until gradually the frequency o~ attacks diD~inishes. I:)ccasioslally, however, recurrences may appear over the rest o~ the individual's life~ The reappearance of herpes infections is then often tri gesed by ~tress, ~ati~ue ~ exposure ts~ sun, ~crauma, 20 feYer, or menstruation~
~ , . . .. . . . . . .
Other complications may develop in those who are afflicted with a herpes simple~ v~rus. If a person sufferirlg from herpes simplex touches a sore or blister and then rubs his ~yes, he may develop a serious eye 5 in~ection known as herp~s keratitis. Thousands of Americans annually lose their sight because oX this disea~e .
F~r women, genital herpes simplex carries sp~cial ri8ks. To beeirl with, genital herpes simplex has been linXed 'co cancer of the cer-vix. Female herpes victims are five co ~ev~n times mor~ likely to develop cervical cancer ~han slon-infec~ed females. I;enital herpes simpïex can also cause serious bisth defects. ~ pregnant woman with an actiYe genltal herpes simple:~ ~nfection faces a fifty 15 percent (50%) chance of pas~ing the diseas~ to her baby as the child passe~ throu~h the birth canal. ~bOue f~ty pereent (50%) o~ th~ new~orn inf~nts wh~ dev~lop herpes ~impl~ die o~ the in$~ct~on; ~eventy-five percent (75%) o$ tho~e who survive suffer from blindness or brain damage. Fortunately9 if ~ores are ~ou~d clo~e to ~he time of delivery~ the doc~or ca~ p~rfor~ Caesarean-section tn prevent infection of the ~ewborn as i~ pas~e~ through the ~irth canal.
Most Amerioans hav~ been expo~ed to th~ herpes simplex virus; indeed, ei~h~y peroent (80'~ of the ~merican population carr~ he herpe~ ~implex virus, and --5~
an~ibodies against the virus hav~ been found in up to ninety-fi~e percent (95%) of blood samples tested.
Although some people never experience ~ymptoms, (possibly b csuse their immune systems repulse the virus so it cannot sustain its attack), abou~ ~even out of eight pcople who come in se~ual contact with the herpes s~mplex virus.will contract an inection. It is estimated that fro~ thirty (30) to seventy (70) million Americans suffer ~ccasionally from ~he ~ost comm~n form of herpes simplex infection, that of coldsores. Moreover, it is estimated that from five (5) to twenty ~20) ~illion Americans ~uffer ~rom ~nital herpes simplex, and ~hat each yeas, half a ~illion more Americans ~oin these ranks.
Since there has pseviously e~isted no known effectiv~ tre~t~nt for herpes si~plex, the total number of perso~s inflicted with herpes ~i~plex continues to increa~e. Sc~entists have tried ant re~ected ~any dif~erent ~reatments or herpes such as vitamin C, zinc9 e~her9 and ice packs. It i~ eYitent ~a~ in the absence of a treatment for herpes simplex, this relatively new Yenereal disease esuld potentially reach epidemic propor~ions.
B. Eczema Another Herpesvirus disorder which plagues many people is atopic eczema. Eczema occurs in primarily three forms (1~ the infan~cile form, (2) the adult form, and 5 (3) the localized ~orm.
The infantile form of eczema ~ay first appear soon after birth, oft . n by the fouroch rnonth of the infant ' s life. Infantile eczema is generally manifested as pr~ce~s~s which n~ay be red, dry, slightly ~caly, cracked, 10 and excoriated, or sometimes moist and oozing. Infantile ecæema is most ~requently manifested around the face, scalp, n~clc, and diaper areas. û}der children and young adul~s g~rlerally experi~nce ~nanifestation of the disease in the flexural areas and the cheeks~ fewer than half 15 oX the individuals inflicted with infantile eczema, th~
dis~ase clear~ up by che age of ~our, yet even in these individuals, the disease may occur at a later age. The majori~cy o~ eczema victims ~till experienc~ occasional ~lar~ ups through the young adult yes~s, up ur~til about 2Q the age Qf thirty, ~t which ~ime the disease usually disapp~ar~ .
The adult orm of ecze~a is generally manifested in the antecubital and popliteal areas, and i~ ~ome rases around the hands, feet, and face. The infected ~kin is ~enerally dry 9 erythematous, and excoriatet with bacterial crusting and redness.
The localized form of eczema, which occurs in diverse individuals 9 iS pri~arily ~anifested around the wrists, ankles, hands, feet and ear~, as well as the perianal, perivulvar, and scrotal regions.
~y far the worst consequence of atopic eczema is the pruritis or itching which is associated with this disease. Those inflictet with atcpic eczema often find pruritis to be a life-long companion. Any relief to be had from such intolerable i~ching is gratifying to say the 15 lease. There are many ~actors which play a role in the occurrence of atopic eczema, such as dietetic and emo'cional factors. Moreover, seasonal fluctuation~ arP
a~ important factor with ~topic eczema g2nerally becoming worse during the winter season.
One of the greate~t fears of those who are inflicted with atopic eczema, ~s that these individuals are generally more suscep~cible to ~iral infectiorl, and in particular, ~o infestation by a herpes simple7c ~irus or a ~raccinia virus. Additionally, ~chose sufferinE~ fron~
a~opic eczema are abnosm~lly ~usceptibl~ to er~vironmerltal irriltants,. Consequently, tho~e inflicted wi~h 'che disease are of~n advised to wear clothislg which is soft and light9 So ~t~y away from heat gources; to take brief baths or showers not e~ceeding five ~inutes and using a ~inimal aMount of soap; to avoid primary irri~ants such as paints, cleansers, solvents, ohemical sprays, dusts, and the like; and som~time~ to change their residence to a wan~, dry temperate, unvarying cli~ate where temperature e~tremes are rarely experienced.
Although there is ao Xnown cure for atopic eczema9 ther~ are various helpfu~ treatments which all have one goal in oommo~: ~o stop the intolerable itching that accompanies atopic eczema. Examples of these treatments include antiseptics, for e~ample antibacteral cleansers such as Betadine ~a registered trademark ownet by Purdue Frederick Co.; Norwalk, Connecticut 06856) a~t Hibitaine;
topical glucocorticoid creams; sys~emic glucocor~icoids;
antipruritic agents; and an~ibiotics. Although the atopic and systemic glucocorticoid trea~ments have proven ~ost effective in treating long-continued atopio ecze~a, adverse topical and systemie efects are often experienced when such treatments are used. Co~sequently, adverse effects in those undergoing glucocorticoid traatments must be carefully monitoret.
It would, there$ore~ be estre~ely desirable to provide an effective tseatme~t for various disord~rs caused by the Herpesviruse~ especially herpcs simplex.
~oreov~r t it would be desirable to provide an improved treatment for Herpesvirus disord~rs such as ecze~a, which i~ safe, having no kno~n ~9id~ effects ~ ~ny body locations. Such treatments are describet and claimed herein.
C. Acne A common skin disorder which plagues nearly all adolescents at scme time or snother is that of acne vulgasis (comm~nly referred to as "acne"). The peak incidence o acne occurs at about ~ourteen (14) years of age in girls and sixteen (16) years of age in boys9 with the ~ost severe cases in boys tending to occur e~en later.
Although ac~e has generally been considered a teenage problem, it is a disease for those wh~ are in their ~wenties and thirties as well. There are few diseases which p~oduce more psychic trauma9 malad3us~ment, insecurity, and ~eelings of inferiority than does acne.
The cause~ and factors influencing the development of ~cne are many, and generally nnt well unders~aod. Acne is n~rmally manifestet in a variety of lesions, including comedomes, papules, pustules, cy~ts, and æcaTs. These 4~
lesions occur in the s~in areas ha~ing the greatest concen~ratinn of sebaceous glands, ~., the face, central chest, ~nd ~pper back. In severely affec~ed subjects, lesions may also appear on the arms, back cf the necX, lower bacX, buttocks, and thighs.
I~ some adolescents, acne is ~anifested by nothing ~ose than a ~ew ~czttered pustule~ and oomedomes that have a relatively short duration and produce no permanent affeets. Other ad~lescents, on the other hand, develop more extensiYe acne that not only persists, but also produces per~anent pits and scars. The lesions which are generally responsible ~or the scars are the tender, red pustu~es and cysts. Some surveys indicate that over two percent (2%) of all high school ~tudents have a severe ~orm of acne.
Many differen~ treatments for aone have been developed over ~he years; however9 the effectiveness of known treatments with respeet to relatively diffi~ult acne problems has been rather limited. For mild cases of acne, regular shampooing of the scalp and dai~y use of sn abrasive ~cap on the acne-~nfected skin are typical of recommended tre~t~ents.
~ os treating ~oderate cases of Acne, preparations for dsying and peeli~g the skin area ~ubject to coDedomes, papules, and pustules are ~fgen recommended. ~ome typical preparations for the treatment of moderate arne include a powder-base ~hake l~tion containisll; re~orcinol and sulfur;
---ll--benzoyl pero~cide; topical ~ntibiotics ~uch as erythromycin and clinda-nycin; oral antibiotic~ such as tetrscycline;
retinoio acid (vitamin A acid); as well as modera~ce irradiation wi~ch ultraviolet light.
For treating n~ore severe cases of acne where pustular and cystic lesions cause scarring, a ~cotally safe treatment has preYiously not been found. Some preparations which have been used to treat severe cases of acne include those containing antibiotics, Kluc~corticoids~ or hor~ones. Many ~ystemic antibi~tics carry undesirable or unwarranted side effects snd risks, thus restricting the use o antibiotics ~o those which are ~ild and relRtively safe, such as erythromycin and tetracycline. ~ndesirable side effects and risks are also experien~ed fsom the use of glucocorticoids and h~rmones.
F3r example, æome ide effects from estrogen-pro~esten medications (a typical hor~one treatment) include thromboembolic disease, ~allbladder disease, strokes, myocardial infarcts 9 hepatic tumors, hypertension, and endometrial cancer. Moreover, the oral ingestion or topical application of ~he female hormcne estro~en by males may result i~ other undesirable side effeo~s 9 such as the emergence of femini~e characteris~ics.
Additi~nally, antiandro~ens, ultraviolet ~ight, 25 cryotherapy using 301id oarb3n dio~id~ or liquid nitrogen, minor ~urgery, chemosurgery, and eYen ~- ray therapy have ~en used in the trea~cl22nt o~ ~evere caæes of aorae. ~s wi~h the other prçparati~ns OT treat~e~ts, certain risks or undesirable consequences are i~herent in each o these treatment~ as well. One imp~rtant undesirable charact~ristic of most all of the prior ar~ acne tre~tments 5 i~ tha~ ~he effects of these ~reatm~nts are often felt throughout the body, not just the localized skin area re~uiring treat~ent.
D. Perioral Dermatitis ~no~her relative~y comm~n skin disorder is perioral denmatitis. PeriDral dermatitis, which primarily plagues young adult women, is less co~mon among ~en and cccurs ~ccagionally in young children. This disorder is usually manifested 8S a localized grouping of red papules, vesioopapules, and papulopustules around t~e lip~, ~outh, chin; paranasal area, and even the ~pper eyelids. Perioral ter~atitis lesions often burn, and exaoerbations and se~issions are frequent. Moreover, the lesions associated with perioral der~atitis generally worsen with pregnancy and menstruation. Othes ~sctors which ag~re~ate perioral 2Q dermatitis lesions inciude heat and perspirati~n.
Generally9 aft~r th~ee ~o ~ix ~onth~ from on~et, the lesions finally disappear.
Perioral denmatitis has proven to be resistent to ~os~ therapy, althou~h ~ome treatments have been found to be ~mewhat beneicial. Som2 of these treatment~ include ~1) tetracycline; (2~ a lZ hydr~cortisone preparati~; (3) the avoidance ~f all cosmetics, e~cept f~r lipstic~ and ~34~
-13-.
~ascara; and (4) dail~ cleansi~g with soap. The long-~onti~ued use o~ po~ent topical glucDcorticoids has been known to protuce the adverse effects ~f perioral der~atitis. Therefore, glucocorticoid treatments which are used to treat perioral dermatitis lesions fflUSt be limitot in strength, or the di~order can be se~erely complicated.
It would, therefsre, be a ~igni~icant advancemen~ in the field of dermatol~y to provide a ~ore effe~tive treatment for acne, a~d ~specially for extremely se~ere cases of acne, which is safe, having n~ known side effects in any body locations. Additionally, it would be another significant advancement tG provide an effective treat~ent for perioral dermatitis, and especially a treatment which woult avoid the adverse effects o~ treatments such as glucocorticoid treatments. Such treatments are dPscribed and clai~ed herein.
Brief 5ummary snd Ob~ects of the In~ention The pres~nt invention relates to a treatment for various types of disorder~ cau~ed by ~erpesvisuses, and ~ost importa~tly, to a treatment for herpes simplex and eczema. This nov~l combinatio~ he~pes simplex ant eczema treatment compri~es applying a preparation to the ~nfected skin area; the preparation comprising ~ carrier 25 ~dicant (such a~ hydrophilic ointmen~) to which is added a small amount of triacontanol. This prepara~ion may be periodically appl~ed to the infected ~kin area as n~eded.
-The activ~ ingredient in the preparation, triacontanol, has proven to be safe and has no known side effects anywhere in the body.
It is, therePore, an object of the present invention to provide an effective treatmen~ ~or disorder-~ caused by a Herpesviru~, and most especially, for herpes simplex, eczema and shingles.
A further ob~ct of the present invention is to provide a ~opical treat~ent for disorders caus~d by a Herpesvirus in which only the in~ected skin area is exposed to the ~edicant treat~ent.
The present invention also relates ~o an improved acne treatment which is effective even for extremely ~evere ca~es o~ acne. MoreDver, the present invention 2elates to an e~fective tr~atment for pesioral dermatitis. This novel combination acne and perioral de~m~ treatment coMprises applying a preparation t~ th~ infected skin : area; the prepar~tion comprising a carraer medicant (such a~ hydroph~l~c ointment) to whioh i~ added a small a~ount of triacontanol. Thi~ preparation ~ay ~e periodically appli~d to the infected skin area a~ needed. The ac~ive i~gredient in the prepar~kion, triacontanol, has proven to be safe and has no known side effects anywhere in the body.
It is, therefore, ~n obJect of the present i~vention to prov~de an improv~d acne treat~ent which is safe, and effecti~e a~ainst even severe cases of acne.
.
Another object of the pre~ent is~vention is to pr4vide an effective treatlDent ~r peri~ral dermatitis.
A further object o~ the present invention is to provide a ~copical treatment for acne and perioral 5 derma~i~cis in which only ~he infected ~kin area is exposed to the medicant trea~men2:.
These and other ob~ect$ o the present inv ntion will become mo~.e fully appasen~ in view of the followinE
detailed description and appended clain3s.
Detailed D~scription o the _eerred i:mbodiment The present invention relates to a method and composition for treating skin infected with a Herpesvirus. Each of the treatments for the variou~ types of ~Ierpes~7irus disorders ~ e . ~ ., herpe~ simple:~ , eczema and shingles ) is ~ubQ~antially ehe same, ant includes the topical application o a preparation comF~rising a carrie-:
medican~c containing a smalï amount of triacon~anol. The triacontanol preparation Dlay be applied periodically to an infected skin area as needed. Indeed, clinical experiments indicste that the preparation may be applied several times daily with~ut identifiable side effects.
Consequerltly 7 the preparation ~ay be applied whenever rleeded to all~ria~e di~comfor~c or t~ clear up lesions.
Shortly after applica~ian o~ the pr~paraticn 'co 8 herpes 25 simple~ lesion, the pain arld itching associated with herpes simplex disappear. Repea~ced application causes the herpes simpleac lesion itself ~o disappeas l often within a few day~.
The present invention also relates to a method and COM-position for treating acne and for treating perioral derma~
titis. Each of these treatments is substantially the same, and includes the topical application of a preparation S comprisi~g a carrier ~edicant ~ontai~ing a small amount of triacontan~l. The triacontanol preparation may be applied periodicaily to an infected skin area as needed. Indeed, elinical e~periments indicate that the preparation may be applied ~everal times daily with~ut identi~i~ble ~ide ~ eff~cts. Cons~quently, the preparation ~ay be applied whenever needed to alleviate discomfort or to clear up lesi3~s.
The active ~ngredient in ~h~ preparation is triacon~anol. Triacon~anol, slso known as melissyl alcohol, myricyl a}cohol, or hydsoxytriacontane, is a strai~h~-chain~ aliphatic, thirty carbon waxy alcshol hsvi~g the formula 3(~H2)~H20H- Al~hough triacontanol has been found usefu~ for such pu~po~es as the f~ti~ization of rops, to the inventor's knowledge$
triacontanol has n~t been used as the active ingredient in ny medicsl treatment.
~5 ., .. ., . ~ .. " . . . .. . . .
Experimental ~pplica~ion of tr~acontanol to skin inected with acne or a Herp~svinYs shows that triacontanol ha3 the following advantsgeous qualities: -~1) it remov~s pain and l~ching; t2) $t clears up lesions 5 sss~ciat~d with Herpesviruses s~ch as herpes ~implex lesion~; (3) iS is anti-infla~4ato2y; (4) it res~ores lipid levels on the skin to normal levels (imp~rtant with respect to Herpass7irus disorders ~uch as ~czema); (5) it i5 virus and bacteria static; and ~6) it is safe and has no 10 knowrl side ef~ct~ ~n arly body locat$ons.
Experimental ~pplicati~n ~f triacontanol ~o skin infected with acne or perioral dermatitis ~hows that ~criacontanol has the followin~ advantag~Gus qualities:
(1) it rem~ves pain and i~cching; (2~ ît clears up acne 15 lesions and perioral dermatitis lesions; (3 ) i~c is anti-in~lamma~cory; (4) it rest~res lipid levels on che skin ~co nDrmal levels; (5~ i~c is virus and bacteria s~atic; and (6) it is safe a~d has no Icnown side effects in any body 1 Q cat ions .
~o The triacontanol preparation ls psepared by simply ~ixing a very s~all qua~tity of triacontanol, about one hundredth of one per~ent (O.OlX~ by weight, with a medlcant base u~til thoroughly blended. Although 0.01%
~riacontanol ha~ bee~ found sufici~n~ for effeo~ive 25 tseatment, qu~ntities much s~ ller than ~his are also llkely ~o provide effect~e treat~nt~
An important cons~deaation in the preparation is the choice of an appropriate medicant base. The selected m~dicant base must be co~npatible with the triacontanol so as to Tllai~cain it in active form for effective 5 applical:ion. One oiTltmerlt which has beer~ employed in the present triacontanol invention i~ a standard VSP
hydrophilic ~intment; a thousand gram~ of which con~ains the following compoun~ ~n the indicated amounts:
Hydrophili c Oint~er~ t - USP
ComPound Amount Methylparab~n 0 . 25g.
Propylparaben 0. 15g.
Sodium l~uryl sulfate 10g.
Propylene glycol 120~.
S'cearyl alcohol 250g.
Whi'se petrolatum 250g.
Purified water 370g.
The ingredients of hydrophilic ointment IJSP, which ointment is commonly as~ailable from a variety of cofnmercial 20 sources, are combined as follows. First, the stearyl alcohol and the white petrola'cum are melted on a steam bath snd warmed to about 75C. The other ingredients axe dissolved ~n th@ purified water snd are also warmed ~e~ about 75C. .A11 ingredients are then D~ixed together and stirred until the 25 mixture cclngeals.
, --lg--It will be understood that the hydrophilic ointment discl~sed above is given by way of example only, and ~hat nu~erous other carrier medicants may also be suitable, such as an oleic acid ointment base. ARain, it i~ the triacontanol, not the carrier medicant, which is the active ingredient in the preparation, the carrier ~edicant merely acting as a carrier for the triacontanol to pxo~ide for the ~ffectiv~ ~pplication of the triacontanol in active form to ehe ~kin. Thus, it will be appreciated that one of ehe most importa~t properties of the carrier medicant is its abiliey to provide ~ufficient contact ~etween the active triacontanol and the skin to effectively treat the skin.
The above-described triacontanol-hydrophilic ointment preparatio~ has been found to be efective in the treatment of disorder~ caused by Herpes~iruses, such as herpcs simple~, eczema, and zoster ~shingles). I~ particular, the preparation has esp~cially been found to be ef~ectiv~
a2ain~t herpe~ simpl~ and eczema. Moreover, the ab~ve-d~scribed triacontanol-hydrophilic ointment preparation has been f~und t~ be ef~ective in the treatment of acne ~nd perioral dermatltis, which is ~omewhat related ~
acne. Experimentally, the best results have been obtained in using the preparation in ehe treatment of perioral ti~is. 5 Experimentally, the best results have been obtained in using the preparation in the treatment of herpes simplex (all types of lesio~s, particularly cold sores) and eczema.
Although the effect of the triacontanol preparativn on other Herpesvirus di~orders such as chicken pox, mononucleosis, fetal infections, fevers, hepatitls, and pneumonia-like illnesses is yet unknown, it i~ well-anticipated that the prepara~ion ~ay al~o be effec~iv~ in the treatment o$ these discrders.
10~ver twenty patients with herpes simple~ lesions in the form of cold sores have been treated with the above-described ~riacontanol-hytrophilic oint~ent preparstion. Upon topiral applicat~on of the preparation, these patients typiGally ount that the itchin~ s8~0ciated with the herpes 15~imple~ lesion3 disa~peared after about 30 to 60 seconds and that the pai~ also di~appeared ~fter about four to eight : ~inutes. The effectiveness of the preparstion in aiding the healing proce~ was found to vary w~th the age o~ the lesio~.
Typically, it was ~ound that if a lesion was treated within four hours sfter its initial ~ppearance, the lesion disappeared completely witbin only a few hours--commonly within about si~ hours. For older lesions, it was found that treatment caused the lesions tn disappear in about one tG
s~ven days~ generally seducing the normal life of the lesion ~y at least fifty perce~t (50%3. Overall, the triacontanol-hydrophilic ointment preparation deorea~ed the normal healing time for herpes simplex lesions by up to eighty percent t80%) or ~ore.
About 25 patients with atopic eczema were also been treated with the above-described triacl~ntaYlol-hydrophilie oint~ent prepaa ation. The a~verage patient ~reated had experienced the symptoms of atopic eczema for at least ten 5 years and had suffered from the sy7npt~ms of atopio eczema durinE~ at least for~y percent (40~ of ~he previous year.
Thes~ patien~s found that their eczema lesions, which wer~
four weeks old on ~he average, were comple~cely healed fi~e days after begiD~ing treatmesl~c wi~h the triacon~anol-10 hydrophilic ointment pr~paration. Thi~ is ir contrast to the three-week healin~ period which i~ generally required when the well-Xnown corti~one crea~ treatments were used.
Moreov~r9 the seYere itchinE a~socis~et with the eczema lesions disappeared within two hours after application of 15 the triacontanol~hydophilic ointment preparat~on, whereas the cc~rtis~ne rrean~s requirecl about two weeks to di~pell ~che ltohing. Additionall3~ t the pain and sores~es~ associated with th2 lesions commonly disappear2d within only a few minutes ster application o th2 triacontanol-hydophilic 2~ oint~ent p~eparation, a~ opposed to about five days for the cortisone ~ream~. ~inally, the triacontanol-hydrophilic oint~ent preparation decreased thQ normal healing time for t~e lesions dra~atically.
Clinical studies were conduct~d on about ~ifteen patients who8 on the average, had experienced perioral derma~i~is over a period ~f at leas~ three years, and had experienced manifes~ati~ns of the disDrder at least twice a year. Nor~ally, ~hree ~o 5iX months were required to heal the perioral de~matitis lesions of the~e pstients. After treatment ~ith the triacontanol-hydrophilie ointment preparation o~ the present i~vention, the time required for healing wa~ decreased dramatica~ly. Moreover, the itching ~s~ociated with perioral dermatitis typically disappeared within only a few secsnd~ aft~r application of the triacontanol-hydrophilic oin~ent preparation to the lcsions.
One of the significa~t advantages of usin~ triarontanol ~s the active in~redient in the treatment of the present invention is that triacontanol has prove~ itself to be safe.
Indeed, it occurs naturally in al~al~a, honey, an~ in the waxy portions of several edible plants. Reeently, it was found that triacon~anol dramatically increases croy yields when used as a fertilizer. A group at Michigan State University discovered that when as little as five milligrams sf triacontanol we~e mixet with 30 to 4Q gallons of water in the treatme~t of one acre of crops 9 grow~h was increased by an av~rage of 12 percent. Since triacontanol is a common plant constituent, it ~ not unusua~ for on~ to co~sume enough tri~con~a~ol in on~ ~eal to treat at leas~ an acre oP
crops .
~ nc~her indication ~ha~ triacontanol is safe is ~che fact that it is fousld naturally ~n beeswa~ ~8 ~ p~lmitate e~'cer a2ld possibly, in e~ctremely s~all amoualt~, as the ~imple alcohol itself. Beeswa~c has be2n used for many years as a 5 stifeninl2 agent in many phaxmaceutical preparations such as eerates, oint~ents, pastes, and petroxolins. Cerates are ~os'cly usetl ~s dressings for in1amed ~kin ~urfaces and s:oT~tain suf~icient b~eswa~ co give them a desired co~siste~cy. Moreover, many cosmeti~ prepasations such as 10 all-purpose creams, night cIeams, vanishing creams, lotions, ~ascaras, lipsticks, cream lip rougQ, and face and body makeup contain significant amounts o beeswax. Thus, the long-time use of beeswax-containing preparations may proYide a basis for the belief that ~riacontanol is safe when applied 15 topically.
Althou~h found in many preparations presently on the market, ilt is uncl~ar why3 if any triacontaslol is presen'c in ~eeswasc as the free alcohol, it is not 3cti~re a~ainst h~rpes plex and oth~r Herpesvirus ~isord~rs; acne arld per~oral 20 de~atitis. First of ~ c~ present ~n becswax ~s th~ palmita~e, it is thought that triacont rlol i~
not ~LC'ClYc wher~ in kh~ fosm of ~ palmitate ester. Iqoreover, it i~ ~os~ecture~ ~ehat even i~E a very small amount of tria~ontanol is present as a iEree alcohol in 25 bee~wax, perhap~ the amount i5 ~COO 3mall to be ~ffective or perhap~ the enviaor3men'c iR~posed by ~he o'cher constituer~ts of ~eeswax in ~om~ ~y prohibit~ th~ triiacontsnol froal having any ~ffect. This supposed inhibitive effect could be due in part ~o hydrophobic interaction between ~riacontanol molecules in thè beeswax environment. Additionally, the inactiYity of ~y ~riacontanol ln beeswax might also possibly be explalned by the inability of the ~kin to ef~ctively ab~orb any triaconta~ol fro~ th~ beeswax e~visonment. Furthermor~ it ~s al~o pos~iSl~ that very close cont~ct between the triaconta~ol and the monomoleeular cell wall o~ the virus is requiret for effective treatme~t.
Such clos~ conta~t could very well be inhibited by the beeswax environment surrounding any triacontanol which might be present. Whatever th~ reason for the ineffectivenes~ of beeswax ~ treatin~ Herpesvirus di~orders, ~cne ~nd perioral dermat~t~, for purposes o~ the present invention, it will bé appr~ciated that the choice of an appropriate ~arrier ~edicant or ~he triacontanol such as the hytrophilic ointment described hereinabove, is very important.
It wil~ be appreoiated that the invention may be embodied in other specific forms without departing from its spirit or esse~tial characteristics. Th~ foregoing descriptions are to be co~idered in all respects only as illustrative ant not restrictive. The scope of the invention i~, therefor~9 indicated by the appended claims rather tha~
by the foregoing description. ~ll changes which come within the meaning and range of e~uival~ney of the claims are to be mbraeed within thelr ~cope.
SD 25 ~
~ s oriyinallv disclosed, a triacontanol~ointment preparation is applied directly to the infected skin area for treatment for disorders caused by ~erpesviruses such as herpes simplex, eczema and shingles, as well as for acne and pe~ioral dermatitis.
In an additional aspect, the inventlon relates to a method for treating inflamma~ory skin disease and more particularly to a novel method for treating human skin infected with viral infections such as, ~or example, Herpesvirus, but as well as to the treatment of other infections of the skin where inflammation is a problern, By inflammation is mean~ the destruction and repair of the tissues in response to irritation, and the means whereby the irritant is removed.
Such a definition places no limits on the amount of the response or the degree or kind of irritation.
Because irritation by the normal products o~ growing and dying cells is related to the process of intercellular communication that occurs physiologically, inflammation merges with the normal behavior of ~issues. When minimal it may differ only in degree rom the normal physiological process by which tissues control their requirements from their ~lood supply.
Inflammation is necessary for repair as well as for the removal of irritants. However, repair, as in wound healing, differs only quantitatively from those processes which control the normal growth and contour of the tissues.
~ SD 26 ~
S~elling of the tissues is initially due to edema fluid, but in more chronic inflammation white cell infiltration may make a main contribution~ The tissues themselves often increase in sizeO Thus acanthosis and an increase in the papillary vasculature is a usual response of the epidermis and upper dermis to irritation.
A papular lesion following an insect bite may show a considerable increase in the bulk of the tissue which may persist after the initial edema has been resolved.
Pseudo-epithiliomatous hypertrophy is not unusual in uncontrolled inflammation.
Heat is a usual consequence of increased flow of blood through the skin. In acute lesions the skin may be heated as a direct result of local increase in metabolic rate. In chronic inflammation neither local metabolism nor blood flow may be increased, and the skin may feel cold. Heat loss cannot be exactly correlated with redness, because, areas of fast flow may be on the border of a more congested and slow~flowing system.
Thus conduction of heat to the surface of the skin may be considerable over a large, deep arteriovenous fistula while the upper dermis may show all the effects of severe stasis consequent on raised venous pressure.
The sensations that accompany inflammation of the skin include burning, stinging, itching and tenderness, and are thus more varied than in most internal oxgans.
Which of these sensations predominates depends in part on the site, depth, in-tensity and duration of the inflam~
,f' -~
~ ~D 27 ~
matory process~ Thus in urticaria stinging ma~ accompany transient superficial lesions, itching is the usual sensa-tion in papular urticaria or in lesions due to histamine release, while pain and tenderness may accompany deeper lesions of long duration, as in delayed pressure uticaria.
Inflammation is a response to any irritation, and the mechanism applies equally to infection, sunburn, abrasions, contact dermatitis or the various patterns or angiitis seen in dermatological practice. Studies of the effects of injury to the skin show early and delayed phases of the inflammatory response, and these are similar whether induced by trauma such as pressure or by ultraviolet irradiation, or any of the factors listed.
It would be extremely desirable to provide an effective treatment ~or inflammatory skin diseases.
This additional aspect of the invention is based upon the discovery ~hat triacontanol has been found to be an effective agent for treating inflammatory skin diseases infected with viral infections such as Herpes~
virus or other skin diseases such as dermatitis (eczema), contact dermatitis, seborrheic dermatitis~ atopic derma-titis, scaling papular diseases such as psoriasis and the like. The invention will be described in greater detail in conjunction with the treatment o~ Herpesvirus infections such as herpes simplex infections and atopic eczema hut as will appear more ~ully hereinafter the present invention is not limited to these skin diseases as other skin diseases where inflammation is a problem ~ `
~ ~D 28 have been successfully tre~ted with triacontanol~
The no~el anti~inflammatory of the present invention, triacontanol, is preferably used in association with a pharmaceutically acceptable carrier, such as a hydrophilic ointment, designed to be applied topically to human skin infected with viral infections or other skin diseases where inflammakion is a problem.
Thus the present invention relates to a method for treating inflammatory skin disease. Each of the treat-ments for the various types of dermatitis is substantially the same, and includes the topical application of a preparation comprising a suitable pharmaceutically accept-able carrier containing a small amount of triacontanol.
The above-described triacontanol-hydrophilic ointment preparation has been found to be effective in the treat-ment of viral disorders such as dermatitis caused by simplex, eczema, and zoster (shinglesl. ~he preparation has also been found useful in the treatment of other skin diseases such as seborrheic dermatitis, contact dermatitis, atopic dermatitis and psoriasis. Moreover, the triacon-tanol-hydrophilic ointment preparation has been found to be effective against acne and perioral dermatitis~
Experimentally, the best results have been ob-tained in using the preparation in the treatment of herpes simplex ~all types of lesions, particularly cold ~ .
-s, ,~
~ SD 2 sores~ and eczema, ~lthough the effect of the triacon~
tanol preparation on other Herpesvirus disorders such as chicken pox, mononucleosis, ~etal infections, fevers, hepatitis, and pneumonia-like illnesses is yet unknown, it is well-anticipated that the preparation may also be effective in the treatment of these disorders.
Over thirty patients with herpes simplex lesions in the form of cold sores have been treated with the above-described triacontanol-hydrophilic ointment prepara-tion. Upon topical application of the preparation, thesepatients typically found that the itching associated with the herpes simplex lesions disappeared after about 30 to 60 seconds and that the pain also disappeared after about four to eight minutes. The effectiveness of the prepara-tion in aiding the healing process ~as found to vary withthe age of the lesion. Typically, it was found that if a lesion was treated within four hours after its initial appearance, the lesion disappeared completely within only a few hours -- commonly within about six hours. For older lesions, it was found that treatment caused the lesions to disappear in about one to seven days, generally reducing the normal life of the lesion by at least fifty percent (50%). Overall, the triacontanol-hydrophilic ointment preparation decreased the normal healing time ~5 for herpes simplex lesions by up to eighty percent (80%) or more.
Analysis of the data rom thirty subjects indicated that they had herpes simple~ for variabls lengths of time, , -. I
~ ~D 3a ~
from one to 45 years, ~ith a mean of 12 years~ In this group, herpes reoccurred one to 18 times per year with a mean of six times per year.
Triacontanol signîficantly reduced healing time in the 27 cases where healing time was indicated pre~ and post-treatment (:pr. O~Q001). The mean healing time for previous lesions was 10.9 days with a range from 3 to 21 days. The mean healing time after treatment with triacontanol was 4.4 days with a range of 1 to 14 davs.
Twenty-six out of twenty-eight (93%) subjects indicated that triacontanol decreased healing time.
When further asked to quantify how much triacontanol decreased healing time, the mean response was an 80%
decrease.
Forty patients with atopic eczema were also treated with the above-described triacontanol~hydro-philic ointment preparation~ The average patient treated had experienced the symptoms of atopic eczema for at least ten years and had suffered from the symptoms of atopic eczema during at least forty percent (40%~ of the previous year. These patients found that their eczema lesions, which were ~our weeks old on the average, were completely healed five days after beginning treatment with the triacontanol ointment preparation. This is in contrast to the three week healing period which is generally required when the well-known cortisone cream treatments were used.
As shown below treatment for vaxious types of ~ SD 31 ~
disorders caused b~ skin inflammation and most importantly, an anti~inflammatory treatment for the Following diseases as set forth in Tables 1-3 has been successfully used.
T_~le~l .. . .. . ~ ~ ~
V'ral disorders respon5ive to triacontanol Patients Herpes Simplex 30 Shingles 5 \Ta~le~2 Disorders generally responsi-ve to triacontanol Patients 10 Seborrheic dermatitis 34 Eczema ~o Lichen Simplex Chronicus 8 Pruritus ani 3 Psoriasis 12 15 Later phase of contact dermatitis 12 Later phase of irritant dermatitis 20 Xerosis 22 Table 3 Disorders less responsive to -triacontan~l ~Pa*ien~s 20 Lichen planus 2 Dermatitis herpetiformis Lichen schlerosis et atrophicans ~wJ '
Claims (8)
1. A chemical composition for the treatment of inflammatory skin disease which comprises a hydrophilic ointment and from about 0.01% to about 1% by weight of triacontanol, said triacontanol being present in an effective amount for the treatment of inflammatory skin diseases.
2. A composition for treating skin infected with acne, perioral dermatitis, or Herpesvirus, which comprises an effective amount of from about 0.01 to about 1% by weight of triacontanol together with a pharmaceutically acceptable carrier medicant.
3. A composition as defined in claim 2 wherein the carrier medicant is a hydrophilic ointment.
4. A composition as defined in claim 1 or 2 wherein the percentage of triacontanol blended with the carrier medicant is about 0.01% by weight.
5. A chemical composition as in claim 1 or 2 for treating acne, perioral dermatitis, or Herpesvirus, comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
6. A chemical composition as in claim 1 or 2 for treating herpes simplex, comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
7. A chemical composition as in claim 1 or 2 for treating acne and perioral dermatitis comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
8. A chemical composition as in claim 1 or 2 for treating eczema and shingles comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
Claims supported by the Supplementary Disclosure:
SD9. A chemical composition as in claim 1 wherein the inflammatory skin disease is one of Seborrheic dermatitis, Lichen Simplex Chronicus, Pruritus ani, Psoriasis, Later phase of contact dermatitis, Later phase of irritant dermatitis, Xerosis, Lichen planus, Dermatitis herpetiformis and Lichen sclerosis et atrophicans comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
Claims supported by the Supplementary Disclosure:
SD9. A chemical composition as in claim 1 wherein the inflammatory skin disease is one of Seborrheic dermatitis, Lichen Simplex Chronicus, Pruritus ani, Psoriasis, Later phase of contact dermatitis, Later phase of irritant dermatitis, Xerosis, Lichen planus, Dermatitis herpetiformis and Lichen sclerosis et atrophicans comprising:
a hydrophilic ointment; and triacontanol, said triacontanol being dispersed throughout the hydrophilic ointment.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US31797681A | 1981-11-03 | 1981-11-03 | |
| US31807681A | 1981-11-03 | 1981-11-03 | |
| US317,976 | 1981-11-03 | ||
| US318,076 | 1981-11-03 | ||
| US48219983A | 1983-04-05 | 1983-04-05 | |
| US482,199 | 1983-04-05 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1184121A true CA1184121A (en) | 1985-03-19 |
Family
ID=27405963
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000414315A Expired CA1184121A (en) | 1981-11-03 | 1982-10-27 | Treatment of acne and perioral dermatitis as well as for skin infected with a herpesvirus |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1184121A (en) |
-
1982
- 1982-10-27 CA CA000414315A patent/CA1184121A/en not_active Expired
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