CA2255521C - Compositions for treatment of burns - Google Patents

Abstract

The present invention is directed to a composition for treating burns. The composition comprises a therapeutically effective amount of a weak organic acid compatible with human skin, in a suitable carrier delivered at pH 2.5-4.5. The weak organic acid is preferably acetic acid or citric acid and the suitable carrier is preferably an aqueous based carrier, more preferably a gel form, utilizing a Carbopol.TM. as a gelling agent. The composition may also include one or more other agents selected from sun blocking agents, skin moisturizing agents and herb extracts.

Description

TITLE: COMPOSITIONS FOR TREATMENT OF BURNS
FIELD OF THE INVENTION

The present invention is directed to compositions for treatment of burns in which the active agent is a therapeutic amount of a weak acidic solution, preferably a solution of a weak organic acid.

BACKGROUND OF THE INVENTION

Since learning the use of fire, burn injuries and their treatment have been central concerns for human endeavors. Burns due to skin contact with flame, hot surfaces, hot liquids etc. are among the three most common accidents, both at the workplace and at home. In North America, about 95% of all burn injuries are treated by home remedies, 2.5 million subjects seek medical advice for burns annually in the US., about 100,000 of these require hospitalization [Peate, WF, 1992]. These figures do not include sunburn injury.

European figures are similar, with about 5% of burn injuries that come to medical attention admitted to hospital and a mortality rate of 0.2% [Jonsson, CE, 1980;
Hytonen, M et al., 1987; de Roche, R et al., 1994]. Most of the burn injuries occur at home, most are scalding accidents with gender and age distributions varying widely by region, urbanization and education. The institution of dedicated burn units is considered the most important step of progress in burn medicine over the past decades.

The psycho-social impact of burn injuries is dramatic.
Over 95% of costs are incurred by severe injuries, mostly (- two thirds) in terms of lost working days and to a lesser extent for direct care [de Roche, R et al., 1994;
Khoo, AK et al., 1994; Hansbrough, JF et al., 1995].
However, there are essentially no published data that analyze the epidemiology and impact of burn injuries which do not reach medical attention, but which often do cause loss of working days and considerable, if transient reductions in quality of life [Miller, SF, 1977; Mertens, DM et al., 1997]. One of the most commonly occurring such burn injuries are sunburn caused by overexposure to the ultra violet rays of the sun. While most sunburn injuries do not require medical attention, they can cause considerable transient reductions in quality of life and may also result in loss of working days.

The main immediate burn injury problems include pain and primary infection. Scarring and functional impairment characterize the intermediate term. Malignancy represent a long term risk, although this is rare for most burns except those from ultraviolet and other radiation.

Beyond the well known misery of burn pains, the objective threats, severity and prognosis of burn injuries are all functions of injury extent, i.e. surface area and depth of tissue destruction. The total tissue destruction is the sum of cells directly destroyed by heat and the much larger number of cells dying due to local tissue responses including edema, leukocytic infiltration, local mediators, apoptosis and infection. These elements are fundamental and similar to small as well as massive burn injuries, the latter adding systemic responses in a critical care scenario with mortality rates increasing as a quantitative function of tissue loss, infection and post-burn immunosuppression.

The principles of burn therapy have changed little over the past decades, and there is some lack of basic science and animal models for in depth analysis of the cellular and molecular events following tissue burn injury.
There is long-standing consensus for rapid and aggressive intervention following burn injury, including the early use of skin grafting.

One conclusion from this recognized need for rapid intervention is that following the direct tissue destruction by the hyperthermal insult, it is local and systemic biological responses that determine much of the post-injury course. This scenario is analogous to, and may include, the development of shock syndromes which can be by themselves life threatening, independently of the nature and extent of a given injury[Cason, JS, 1981]. However, other than shock, the immediate interference with tissue injury responses following thermotrauma has received little attention beyond general pain relief and precaution against infection [Baxter, CR and Waeckerle, JF, 1988; Brofeldt, BT
et al., 1989].

Secondary cell death due to tissue burn injury responses involves the elements of acute phase reactants such as leukocyte extravasation and mediator release.
Vasoconstriction peripheral to the injury locus but hyperemia and fluid loss within the injured area conspire to reduce oxygenation, accumulate detritus, and activate complement and apoptosis pathways for pronounced secondary cell death. These events create the viscious circle characteristic of even small burn injuries and their misery [Shaw, A et al., 1994; Arturson, G, 1996]. In addition, the injured tissue represents an ideal, immunologically underprivileged target site for infectious agents which can dramatically threaten the recovery process.

While the need to cover burn injuries has long been recognized, ideal solutions are still elusive, and the variety of proposed remedies is profuse, ranging from honey, tree bark and animal urine or dung to potato peels to amniotic membranes, allografts and modern plastics to name but a few.

The use of tannic acids (TA) (or tannic herb eschars) as a burn remedy had been proposed early this century [Davidson, EC, 1925] based upon ancient Chinese texts. TA
is the collective name for a group of illdefined substances which convert putrefiable hide or skin into imputrescible leather. The acidity of these extracts is uncertain, as hydroxy groups from the principal trihydroxybenzene structure are extremely weak proton donors. TA treatment has been linked to liver necrosis in burn patients, even death: in one report 14 of 16 TA-treated patients who died from their burn trauma showed definitive evidence of serious liver necrosis (reviewed in [Hupkens, P et al., 1995]).

SUMMARY OF THE INVENTION

The present invention is directed to a composition for treating burns. The composition comprises a therapeutically effective amount of a weak organic acid compatible with human skin in a suitable carrier.

In an aspect of the invention, the weak organic acid is acetic acid or citric acid.

In another aspect of the invention, the pH of the composition is between 2,5 and 4.5.

In yet another aspect of the invention, the suitable carrier is an aqueous based carrier, preferably a gel form, utilizing CarbopolTM as a gelling agent.

In yet another aspect of the invention, the composition also includes one or more other agents selected from sun blocking agents, skin moisturizing agents and herb extracts.

In yet another aspect of the invention, there is provided a method for treating skin thermal trauma. The method comprises applying to the affected area of the skin a therapeutically effective amount of a weak organic acid in a suitable carrier.

In yet another aspect of the invention, the skin thermal trauma is a sunburn.

The invention in one broad aspect comprehends the use of a composition in an admistratable form for treating burns and preventing delayed hyperalgesia of an affected area of skin, wherein the composition comprises a weak organic acid selected from the group consisting of acetic acid, vinegar, citric acid and combinations thereof, in a pharmacologically' effective carrier, wherein the pH of the composition ranges from approximately 2.5 to 4.5.

Another aspect of the invention pertains to the use of a composition in an adinistratable form for mediating the perception of pain in an area of tissue damaged by excessive exposure to skin thermal trauma, the administratable form being such as to permit prolonged localized concentration of H+ ions the source of the H+ ions being a composition containing a therapeutically effective amount of a weak organic acid selected from the group consisting of acetic acid, vinegar, citric acid and combinations thereof, dispersed within a pharmacologically effective carrier, wherein the pH of the composition is within the range of approximately 2.5 to 4.5, and wherein said therapeutically effective amount provides prevention of delayed hyperalgesia.

5a DETAILED DESCRIPTION OF THE PREFERRED EMBODIMEN'I'S OF Z'IIE
INVENTION

The present invention is directed to a composition for treating burns where the composition is effective to provide immediate interference with tissue injury responses following thermotrauma. In contrast to topical local analgesics, which do not affect aspects of wound healing, local or systemic responses [Pedersen, JL et al., 1996], the compositions of the present invention provide bot-h, analgesia and distinct effects on the tissue in.jury response which is reflected in the beneficial course of scar-less healing.

The present invention relies on the observed effectiveness of weak organic acids compatible with human skin as a burn therapeutic agent. The effectiveness of compositions of the invention has been shown using, for example, food-grade vinegar, diluted acetic acid or citric acid. Since the common element among these ingredients is the hydrogen ion (H+), it is thereby thought to be the active component. Local delivery of appropriately dosed H-+-has a range of unexpected and largely unexplained properties beneficial for the treatment of partial skin thickness thermal injuries due to flame, hot surface contact, scalding, as well as skin surface damage due to overexposure to sunlight. The compositions of the invention have superior effectiveness when compared to any other known burn treatment and/or remedy.

The application of a source of H+ in surface burns is counter-intuitive, as H+ ions can cause burns themselves when encountered in sufficient concentration.

Sources of concentrated H+ (e.g. acids) can cause topical burns and should, thus, be avoided. In contrast, the present invention has established that in small concentrations, H+ ions, delivered by sources such as, for example, acetic and citric acid, are effective for burns therapy. These concentration/dilutions are similar to the acetic acid content of food-grade vinegar and the citric acid content of natural lemon juice, respectively.

Vinegar is as old the human use of alcohol, and by around 1000 AD, hand washing with vinegar was recommended for - what now would be labeled as - antimicrobial hygiene in ancient medical texts from China and Arabic sources such as Shen Tua (1031-1095 AD) [Chan, EL et al., 1994]. Vinegar is an impure organic acid and a rich source of many volatile contaminants [De, VM et al., 1987]. It has possible antibacterial and antiviral effects, although the mechanisms of this vinegar activity is unknown. Vinegar is approved for human non-dietary use and performs well as the main ingredient of vaginal douches although mechanisms are, again, uncertain [Brinton, LA et al., 1990; Nyirjesy, P et al., 1997]. None of the vinegar uses implies the new properties disclosed here as obvious, despite the fact that many of the now en vogue alternative health care compendia tend to produce all-encompassing broad and scientifically unproven claims for exceedingly lengthy lists of compounds and substances.

The effectiveness of pure acetic acid, sodium acetate and vinegar have rarely been compared [Brighenti, F et al., 19951, and never with respect to antimicrobial activity.
Although sodium acetate is used in some vaginal douches, their effectiveness has not been measured [Chvapil, M et al., 1978]. While acid sensitivity of bacteria is one element of antimicrobial activity, this is insufficient to explain the antimicrobial effects of vinegar, since some common food-borne bacteria are highly sensitive to vinegar, yet they survive gastric acid exposure and cause common intestinal disease [Nishikawa, Y et al., 1993]. There is a considerable amount of published literature on the antimicrobial effects of vinegar [Emili, H et al., 1974;
Larghi, OP et al., 1975; Fasanella, RM, 1991; Karapinar, M
and Gonul, SA, 1992; Nishikawa, Y et al., 1993; Rund, CR, 1996], observations that are finding their way into the food processing industries [Dickens, JA et al., 1994;
Entani, E et al., 1997].

While vinegar treatment of killed chicken prior to freezing was shown to significantly reduce bacterial contamination, there are no published reports on the effects of vinegar on living skin [Dickens, JA et al., 1994]. A widely employed skin application of vinegar occurs in the Pacific Rim Countries where, acting as a nematocyst inhibitor, vinegar is the recommended first aid treatment against potentially life threatening jelly fish stings [Fenner, PJ et al., 1985; Beadnell, CE et al., 1992;
Fenner, PJ et al., 1993].

In vitro tissue culture studies suggested that acetic acid is toxic to human fibroblasts and keratinocytes in concentrations of above 0.025% (reviewed in [Rund, CR, 1996]). This stands in obvious contrast to the effects of the invention consistently observed. These data are also in disagreement with the frequent use of vinegar douches tolerated well and over prolonged periods of intravaginal use [Nyirjesy, P et al., 1997]. The applicability of such tissue culture studies to in vivo tissue is uncertain.

Although exact molecular mechanisms remain to be elucidated, the invention is thought to target the initial oscillations of the viscious circle leading to secondary cell death, thereby preventing secondary cell death with consequent improvement of the post-injury healing process.
Forty two of 43 partial skin thickness burns have been successfully treated with the composition.

While the effectiveness of the compositions of the invention has been demonstrated for reasonably small (<5%
body surface), partial skin-thickness burns and sunburns (<40% body surface) which represent the vast majority of thermal injuries, the compositions of the invention are also expected to have utility in wider applications such as more severe, larger area burns and scalds. Five small (<10 cm2), full thickness skin burns have successfully been treated with the composition. The molecular and cellular mechanisms of the invention's effectiveness require study, but their positive impact on localized burns is dramatic, reproducible, fast and lasting beyond the 1-2 hrs of initial application.

As discussed above, it is likely that the effects of the compositions of the present invention derive from a direct action on injurious tissue responses, an action that stops the collateral damage due to the cascade of local responses to thermal insult. Without the pain and consequent vasoconstriction, without extravasation and consequent edema, infiltration, mediator release and blister formation, healing can and does start unimpeded. It is possible that the controversial antimicrobial effects of vinegar contributes to the remedial effects afforded by sub-neutral pH gels by reducing the local load of infectious agents and thus the risk for primary colonization [Emili, H et al., 1974; Larghi, OP et al., 1975; Fasanella, RM, 1991; Karapinar, M and Gonul, SA, 1992; Nishikawa, Y et al., 1993; Rund, CR, 1996; Entani, E
et al., 1997]. However, infection is not a major problem in the typical household burn addressed as initial and tested target of this invention.

Formulations according to the present invention have demonstrated efficacy treating a variety of accidental and planned partial skin thickness first and second degree, as well as a number of small area third degree burns. In addition, the compositions of the invention have shown effectiveness in the treatment of sunburns in adult volunteers. In these experiments, test subjects were blinded and treated consecutively with different gel formulations that did or did not contain the active ingredient and were otherwise indistinguishable. These experiments firmly established the effectiveness of compositions of the invention.

Specifically, the effects of the compositions of the present invention include:

rapid local analgesia without the numbing of local anesthetics, prevention/rapid reduction of hyperemia, prevention or reduction of local edema, prevention of blister formation, acceleration of wound healing, prevention of depigmentation prevention of delayed hyperalgesia absence of wound infection, absence of scarring and keloid formation.

These effects are newly discovered and disclosed here.
However, a possible antibacterial effect of vinegar and other apolar weak acids is controversial in the literature and, if present, could conceivably contribute to the excellent wound healing characteristics observed following early, transient application of the invention on surface burn injuries.

The compositions of the invention contain a carefully controlled H+ concentration, typically derived from a weak organic acid compatible with human skin, preferably, an organic acid selected from acetic acid, food-grade vinegar or food-grade citric acid. The composition has a pii in the range of about 2.5 to about 4.5. The selection of the pl-H
for the composition is dependent upon the formulatiori used and the ability of the other components in the formulatioi) to tolerate the acidic pH. Preferably, the pH range foi optimum effectiveness is generally about 2.5 to about 4.0, however for the gel formulations based upon Carbopoll, a pH of about 4.2 is preferred as it improves gelling. Carbopoll is a trademark for a cross linked acrylic acid based polymer gelling agent. In a preferred embodiment, the composition comprises acetic acid or vinegar in an amount to yield up to about 0.5 to 5% acetic acid, and 2 to 8% citric acid. In a most preferred embodiment, the composition comprises acetic acid or vinegar in an amount equal to up to about 1% acetic acid and 5% citric acid.

The composition is provided in a form suitable for the immediate application to the burn area. The compositiori may be in the form of a liquid, gel, lotion, aerosol, or may be provided in the form of a dressing for applicatiori to the skin.

When provided as a liquid, the composition may be simply the suitable concentration of the weak organic acid in water with the pH of the solution adjusted to the desired range if necessary. If desired, other water soluble agents such as herb extracts useful for soothing and cosmetic effects may be added provided they do not deleteriously affect the therapeutic properties of the composition.
The composition may also be formulated as a gel or lotion to provide for longer lasting coverage of the affected areas of the skin. The gel or lotion may be a water based gel using a suitable gelling or thickening agent. Alternatively the lotion may be provided'as an emulsion, either an oil in water emulsion or a water in oil emulsion. Such emulsions typically are prepared using conveMtional ingreclients including stiffeners, emollients, = 11 emulsifying agents and humectants. Stiffeners are usually oil-soluble fatty alcohols such as stearyl alcohol, cetyl alcohol, lauryl alcohol and myristyl alcohol. Emollients are usually isopropyl myristate, lanolin, lanolin derivatives, isopropyl palmitate, isopropyl stearate and the corresponding sebacates. Emulsifying agents are preferably non-ionic and are usually sorbitan monooleate and polyoxyl 40 stearate. Humectants are usually propylene glycol, sorbitol, glycerin and mixtures thereof. The ingredients for the emulsion are selected to be compatible at the desired pH range of about 2.5 to about 4.5. Typica].
formulations are characterized according to the followinq where percentages are by weight:

Component % by weight Petrolatum 0-25 Stiffener 7-45 Emollient 0-15 Emulsifying agent 4-16 Humectant 7-40 Weak Organic acid 5 Water q. s . 100 õ_ The composition of the present invention is preferably formulated as a water soluble gel which provides sustained, local H+ concentrations. The gel formulation, for example, can utilize Carbopoli" as the gelling agent. CarbopolT"' is a common gelling agent in foods, cosmetics, prescription and OTC drugs, is highly hydrophilic and rapidly removed under running water. This allows for ease of re-application to prolong the analgesic effects of the composition. While CarbopolT" is one example of a gelling agent, it will be apparent to those skilled in the art that other known gelling agents may be utilized in addition to or in place of CarbopolTw, provided they are effective to form a gel in the desired pH range and do not affect the usefulness of the organic acid.

The composition may also include herb extracts deemed attractive for their purported soothing and cosmetic effects. For example, a calibrated extract of Marigold and Aloe vera may improve odor and provide added soothing properties. Herb extractions can be performed as short term (20 min, 250C) vinegar or 5% acetic acid infusions of dried, powdered herbs at pH 2.7 0.3.

The compositions of the present invention may also be provided as an aerosol, preferably in a pump container to provide a suitable mist spray for application to the affected area. Such aerosol may be simply an aqueous solution of the weak organic acid or may include other ingredients typically provided in aerosols such as stiffeners, humectants, or herb extracts such as aloe vera so long as the additional ingredients do not affect the usefulness of the composition for burn therapy. An advantage of the aerosol form is that it can be applied to the affected area of the skin without requiring direct physical contact with the skin.

The compositions of the present invention may also be provided in the form of a dressing for application to the skin. The dressing can be gauze, or other suitable material which is saturated with the composition of the present invention. The use of the dressing provides a physical barrier aiding in protection of the affected area from potentially abrading contact and exposure to microbial infection. This may aid in the healing of the affected area, especially for more severe burns.

The compositions of the present invention are of particular utility for small household and kitchen burns as well as sunburns, i.e. over 95% of burn/scald accidents in North America.

Delivery of the composition of the present invention as quickly as possible after the injury is an important element for its full effectiveness. Delayed application of the formulation shows slowly lessening effectiveness, but repeated administration hours after the insult has been tested successfully after sunburns to reduce pain, hyperemia and blister formation, and produce relief from thermal hypersensitivity.

Depending on wound depth and area, single or repeated acute application of the compositions of the invention leads to a high degree of functional recovery within minutes and an excellent wound healing course without blistering and scarring even in subjects that tend to develop keloid. In subjects tested on one or more occasions to date, the composition of the invention has not, so far, allowed development of depigmentation and delayed hyperalgesia.

While for most small burns, a single application of the composition of the invention provide effective relief, for optimum healing it is preferred that the composition be applied 2-4 times over the first two hours after the burn trauma.

The present invention has demonstrated, for the first time, that topical application of H+ (hydrogen ion) through an acidic formulation eliminates or, at least, significantly reduces the normal symptoms (hyperesthesia, blistering, etc.) and subsequent complications (infection, scarring, etc.) of first, second and small area third degree thermal injuries. H+ application also accelerates the healing process.

The effectiveness of compositions of the invention has been shown using food-grade vinegar, diluted acetic acid and citric acid. Since the common element among these ingredients is the hydrogen ion (H+), iL is thereby Llioixght.
to be the active component.

In order to prolong the beneficial. effect of 11-+ with:iri the burned area of local thermal injury, the composit.ion is preferabl~ provided as a gel formulation, for example usii-iy Carbopol'940 NF, a commercially available, commonly used thickening agent in food, cosmetic and various health car-e products. In addition, since herbs and/or their extracts have been traditionally used for their soothing effects, Aloe Vera, Marigold, their extracts and similar substarice.,;
may be utilized in the acid gel. However, the possible effects or effectiveness of the latter is independent of and cannot affect the H+ activities.

The properties and therapeutic effectiveness of H-i-application in skin thermal trauma especially for sunburn was empirically established. To date, the exact niolecular mechanisms of low concentration H+ action is not known.

Preferred embodiments of the invention will now be described in the following examples. It is to be appreciated that the invention is not limited to t'Fie specific examples which are merely illustrative of the preferred embodiments.

PREPARATION OF ACID GFT.

Acetic acid and citric acid was each made to 5% (wt/v) in H20 from glacial acetic acid (99.8 %) and solid citric acid monohydrate, respectively. Powdered dry marigold and Aloe Vera were then added to these acid solutions or to commercial, food-grade vinegar to 0.15 % and 0.075 %, respectively. This step is optional and omission of the herbs does not affect the potency of the final products.
The mixtures were stirred at room temperature for 20 min, and cellulose filtered, follqwed by the addition of EDTA to 0.1 %. Subsequently, solid Carbopolm 940 NF was applied slowly to 1.8 % while being stirred at high magnetic setting until the suspension lost granularity. 10N NaOH was then slowly stirred in to adjust pH of the mixtures to 4.2 for their gelling. For every 100 mL of the vinegar and acetic acid gels, 2.8 mL of the alkaline was required, whereas for the citric acid gel, 4.3 mL was required.
Finally, excess air was removed from the gel suspensions by low speed (2000 rpm) centrifugation at room temperature for 5 min.

As a control to the acid gels, a neutral (pH 7.0) gel was similarly made from H20-(herb)-EDTA and CarbopolTM 940 NF.

IN VIVO TESTING OF THE ACID GEL IN SUBJECTS WITH THERMAL
SKIN INJURY

Forty three adult volunteers were recruited into these studies. These subjects had undergone accidental or voluntary partial skin thickness surface burns. They were treated with the compositions prepared as above at pH 4.2, or aqueous solutions of 5% acetic acid at pH 2.7. Some of the test subjects underwent testing on repeated occasions.
This included two out of five near-full thickness (third degree) small area burns: both were successfully treated.
The main measured response elements were:
speed and extent of local analgesia, development and extent of hyperemia, development and extent of local edema, development and extent of blister formation, development and extent of wound infection, time course of wound healing, development and extent of depigmentation development and extent of delayed hyperalgesia development and extent of scarring and keloid formation.

The initial formulations were vinegar-based, but subsequently formulations based on typically 5% acetic or citric acid were developed and compared to neutral pH
(water-based) control gels. All formulations with an H+
source performed in a similar fashion, employing a blinded subsequence (N-of-one) protocol.

The application of a liquid H+ source was reasonably effective to provide pain relief. However, it is preferred if the composition is provided in a carrier medium to maintain the contact of the composition with the skin for extended periods. Such carrier medium may be either a physical object such as sponge, gauze, tissue or towel to contain the liquid in the place of injury or may be a more viscous composition such as a gel or lotion.

Application of the active ingredients in a clear gel form is particularly preferred as it adds benefits intrinsic to a controlled, tested and quality assured product. In particular, a gel provides sustained delivery of active ingredient(s) for a reasonable time as well as a shield from microbial attack. A gel formulation and packaging in UV resistant containers reduces loss of volatiles [De, VM et al., 1987] and allows addition of ingredients to augment its healing properties, smell, cosmetic appeal, transportability and shelf life.

The effectiveness of the burn therapy of the present invention is enhanced by quick application, preferably right after the thermal insult. A period of less than 5 minutes between insult and application is optimal, 10-30 minutes is acceptable. The effectiveness is further enhanced by 2 to 4 repeat applications over the first 1 to

2 hours, especially for relief of pain associated with the thermal injury. Beyond that time frame, further applications of the composition generally do not provide enhanced therapeutic effect. In sunburns where burn trauma is acquired over a prolonged period of time, the effect of the composition is less immediate, and in severe cases may require repeated applications over the first several hours of treatment.

The compositions of the invention are applied liberally over the affected skin area directly and quickly.
Positive results are essentially immediate. The pain relief is dramatic, quick and lasting after single or repeated application within the first 2 hrs of trauma. If the effect is not complete, the composition of the invention can be freely re-applied. This is especially true for the gel which rinses off instantly with water if required.

The immediate perception following application of the composition of the invention is a cooling, soothing effect, followed by receding wound pain. It has been typical that burn victims will pursue whatever activity preceded the accident within some 5-10 minutes and essentially forget the insult. In superficial burns the typical post-burn hyperalgesia disappears within 10-15 minutes, in deeper injuries this process takes a day, but does not impede the ability to have, for example, a normal shower, re-applying if subjective or objective symptoms (edema, hyperemia) linger, as was the case with several small, but full thickness skin thermotraumas successfully treated with the composition of the invention.

The absence of scarring has been observed with all test applications (including the above third degree burns), as has the absence of blistering. This applies as well to superficial, intermediate and deep partial skin thickness burns.

Scar formation is a serious difficulty in burn management, yet the understanding of functional tissue elements and tissue injury responses that drive scar development are in their infancy [Swann, DA et al., 1988;

Carr, CJ, 1992; Robson, MC et al., 1992; Garg, HG et al., 1993; Gibbons, M et al., 1994; Garg, HG et al., 1995;
Ghahary, A et al., 1995; Harland, DL et al., 1997].
Analyses of the mechanisms that prevent scar formation following treatment with the composition of the invention may shed new light and delineate possible new therapeutic strategies in this central area of burn management.

The effectiveness of the composition of the invention in cases of sunburn, including one serious case with burn to some 40% of body surface area has been demonstrated. In sunburns the thermal and radiation injury accumulates relatively slowly and evenly over the affected areas. The composition of the invention was applied within one hour after leaving the sun, i.e. much later in the burn response process than after acute heat burns. The effect of the composition of the invention was dramatic, but much slower.
The impressive hyperemia receded within an hour of freely applying and re-applying the composition of the invention.
By the end of the day, this victim had a lukewarm shower to remove some dry gel residue - the gel dissolves instantly in water - and a thin layer was applied for the night.
There was no sign of sunburn next day, the skin was comfortable to touch. The skin showed no hypersensitivity to re-exposure to sun. However, sunblocks were used more freely. There was development of natural tan, indicating restoration of normal skin functionality.

To the first time user, the effects of H+-based burn treatment in skin burn injuries is little short of miraculous. Collaborators and volunteers commonly ridiculed the process until experienced first hand: pain is very personal.

Based on purely natural, controlled, food-grade ingredients and designed for application to unbroken, if injured skin, the present invention provides a new, innovative and extremely practical home remedy for small burn injuries - the most common of such cases. The present invention provides an attractive, affordable, chemically stable and easily transportable choice for the majority of burn accidents.

Based upon the observations of the effectiveness of the composition in treating small area third degree burns, the compositions of the invention should be effective in treating more severely burned victims.

The dramatic effectiveness of the compositions of the invention in reducing surface trauma responses may imply alternative applications in human and veterinary medicine.
For example, hypo-oxygenation is a shared aspect of burn trauma and ulcerations such as those common in diabetes. If the compositions of the invention affect hypoxic tissue responses, such ulcerations could become a target for H+
therapy.

Radiation injury derived from radioactivity (e.g.
gamma- or x-ray sources) specifically induce apoptosis, and if the compositions of the invention affects apoptosis pathways, such injuries might be targeted by the invention.
Abnormal apoptosis has been suggested in Psoriasis and several other chronic skin disorders and could thus provide a possible target of H+ application. Conversely, abnormal apoptosis is a hallmark of many, if not most cancers.
Further understanding of the mechanism(s) of action of the present invention could lead to the development of specific agonists/antagonists that modify tissue apoptosis responses and provide an adjunct to cancer therapies.

Although various preferred embodiments of the present invention have been described herein in detail, it will be appreciated by those skilled in the art, that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.

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Claims (18)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. The use of a composition for treating burns and preventing delayed hyperalgesia of an affected area of skin wherein the composition comprises a weak organic acid selected from the group consisting of citric acid, citric acid in combination with acetic acid and citric acid in combination with vinegar, in a pharmacologically effective carrier, wherein the pH
of the composition ranges from 2.5 to 4.5.

2. The use according to claim 1 wherein the pH ranges from 4.1 to 4.4.

3. The use according to claim 2 wherein the pH ranges from 4.15 to 4.25.

4. The use according to claim 3 wherein the pH is approximately 4.2.

5. The use according to claim 1 wherein the carrier includes a gelling agent.

6. The use according to claim 5 wherein the gelling agent is a cross-linked acrylic acid based polymer.

7. The use according to claim 1 further including one or more agents selected from the group consisting of sunblocking agents, skin moisturizing agents, herb extracts and antimicrobial agents.

8. The use according to claim 6 wherein the composition further includes an effective amount of a Marigold extract, an aloe vera extract or a combination thereof.

9. The use of a composition in an administratable form for mediating the perception of pain in an area of tissue damaged by excessive exposure to skin thermal trauma, the administratable form such as to permit prolonged localized concentration of H+
ions, to the area of tissue damage and wherein a source of the H+
ions is a composition containing a therapeutically effective amount of a weak organic acid selected from the group consisting of citric acid, citric acid in combination with acetic acid and citric acid in combination with vinegar, dispersed within a pharmacologically effective carrier, wherein the pH of the composition is within the range of 2.5 to 4.5, and wherein a therapeutically effective amount of the composition provides prevention of delayed hyperalgesia.

10. The use in accordance with claim 9, wherein the source of H+ ions is a composition containing a combination of acetic acid and citric acid in an amount to yield up to 0.5 to 5% acetic acid and 2 to 8% citric acid.

11. The use in accordance with claim 10, wherein the composition comprises a combination of acetic acid and citric acid in an amount to yield up to about 1% acetic acid and about 5% citric acid.

12. The use according to claim 9, wherein the pH ranges from 4.1 to 4.4.

13. The use according to claim 12, wherein the pH ranges from 4.15 to 4.25.

14. The use according to claim 13, wherein the pH is approximately 4.2.

15. The use according to claim 9, wherein the carrier includes gelling agents.

16. The use according to claim 15 wherein the gelling agent is a cross-linked acrylic acid based polymer.

17. The use according to claim 15, further including one or more agents selected from the group consisting of sunblocking agents, skin moisturizing agents, herb extracts and antimicrobial agents.

18. The use in accordance with claim 9, wherein said therapeutically effective amount provides prevention of wound infection.