Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/60—Salicylic acid; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M21/02—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
  • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0016—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the smell sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0022—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the tactile sense, e.g. vibrations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0027—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the hearing sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0044—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the sight sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0077—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with application of chemical or pharmacological stimulus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/04—Skin

Definitions

• the present invention relates to methods for (1) reducing the number and severity of acne lesions on the skin of a mammal; (2) ameliorating the inflammation of acne lesions on the skin of a mammal; (3) improving the skin tone of a mammal, (4) treating skin disorders; (5) treating stress related skin diseases; (6) reducing stress and improving the emotional well being of an acne sufferer; (7) reducing sebaceous gland output; and (8) increasins compliance of the administration of anti-acne products.
• the method comprises the administration of a sensory regimen in an amount effective to downregulate the activity of the hypothalamus-pituitary-adrenal (HPA) axis in combination with the administration of an anti-acne composition.
• HPA hypothalamus-pituitary-adrenal
• chronic stress an accumulation of acute stresses
• Acne vulgaris is a skin condition that affects over 85% of all people. The following are four primary factors that lead to the formation of acne vulgaris; (1) increased sebum output resulting in oily, greasy skin; (2) increased bacterial activity normally due to an overabundance of Propionibacterium acnes; (3) plugging (hypercornification) of the follicle or pilosebaceous duct; and (4) production of inflammation by substances leaking into the dermis which cause inflammatory reactions.
• a more detailed description can be found in Cunliffe, William J., Acne, London: Martin Duitz Ltd., 1989, Chapter 1, which is incorporated by reference.
• hypothalamus drives the activity of the mammalian stress response. Specifically, the hypothalamus drives the production of "stress hormones” including catecholamines and glucocorticoids.
• the hypothalamus responds to a stressor by activating the sympathetic nerve endings in the adrenal medulla to produce adrenaline.
• the hypothalamus produces corticotrophin-releasing hormone ("CRH”) which acts upon the pituitary to release adrenocorticotrophic hormone (“ACTH”) which in turn acts upon the adrenal cortex to promote the production of cortisol.
• CSH corticotrophin-releasing hormone
• ACTH adrenocorticotrophic hormone
• the CRH and sympathetic systems participate in a positive feedback loop so that activation of one system activates the other. Since increased cortisol secretion is an indication that the HPA axis has been activated, conversely, a decrease in cortisol secretion would indicate a downregulation of HPA axis activity.
• anti-acne agents for topical use, such as salicylic acid, sulfur, lactic acid, glycolic acid, pyruvic acid, urea, resorcinol, N-acetylcysteine, retinoic acid, benzoyl peroxide, octopirox, triclosan, azelaic acid, phenoxyethanol, phenoxypropanol, flavinoids, derivatives thereof, and combinations thereof, they tend to be slow acting and may have negative side effects.
• This invention will solve the problem of improving acne and acne related conditions through use of sensory stimuli in combination with the use of an anti-acne agent.
• the methods according to the present invention reduce emotional stress, downregulate the HPA axis and improve the quality of life of the acne patient.
• the present invention relates to a method for reducing the number and severity of acne lesions on the skin of a mammal.
• the method comprises the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition comprising an effective amount of an anti-acne agent.
• the invention relates to methods for ameliorating the inflammation of acne lesions on the skin of a mammal and methods for improving the skin tone of a mammal using the method described above.
• the invention relates to a method for the treatment of skin disorders comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition.
• the method can provide at least at least two of the following treatments: (a) reducing the number and severity of acne lesions on the skin of a mammal; (b) ameliorating the inflammation of acne lesions on the skin of a mammal; and (c) improving the skin tone of a mammal.
• the invention also relates to a method for the treatment of stress-related skin diseases such as atopic dermatitis, sebhorreic dermatitis, psoriasis, itch, wound healing, fine lines, wrinkles, pigmentation, and combinations thereof.
• the method comprises the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an active agent.
• active agent means therapeutic agents known in the art to be useful in the treatment and or amelioration of the symptoms of these skin conditions.
• the invention also relates to a method for reducing stress and improving the emotional well being of an acne sufferer.
• the method comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition comprising an effective amount of an anti- acne agent.
• the invention also relates to a method for reducing the visual appearance of shine.
• the method comprises the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal.
• the invention relates to a method for reducing sebaceous gland output comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition comprising an effective amount of an anti-acne agent.
• the invention in another embodiment, relates to a method for increasing compliance of anti-acne products comprising the step of administering a sensory regimen in combination with the administration of an anti-acne composition.
• the methods according to the present invention can be used to (1) reduce the number and severity of acne lesions on the skin of a mammal; (2) ameliorate the inflammation of acne lesions on the skin of a mammal; (3) improve the skin tone of a mammal, (4) treat skin disorders; (5) treat stress related skin diseases; (6) reduce stress and improve the emotional well being of an acne sufferer; (7) reduce sebaceous gland output; and (8) increase compliance of the administration of anti-acne products.
• the method comprises the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition comprising an effective amount of an anti-acne agent.
• mammals include any of a class of warm-blooded higher vertebrates that nourish their young with milk secreted by mammary glands and have skin usually more or less covered with hair, and non-exclusively includes humans, dogs and cats.
• the term "effective amount” refers to the duration of the sensory regimen sufficient to create the desired response, i.e., reduction or down-regulation of the activity of the HPA axis and reduction of total daily adrenocortical hormone.
• the effective amount will vary with the age, physical, and emotional condition of the mammal being treated, the nature of concurrent therapy, the specific regimen employed, and like factors.
• the sensory regimen can be any regimen that is relaxing to the user.
• the sensory regimen is selected from the group consisting of auditory stimuli, visual stimuli, tactile stimuli, gustatory stimuli and olfactory stimuli, and combinations thereof.
• Suitable auditory stimuli include, but are not limited to, music and sounds of nature that are soothing or relaxing to the consumer.
• music is used herein to include instrumental and lyrical compositions; tunes; melodies; harmonies; songs; beats and frequencies such as those from metronomes, tuning forks, bells, beat machines, chimes; poetry and rhymes.
• the music may be of any genre, including, but not limited to, classical, soft rock, easy listening, progressive, country, and show tunes.
• the sounds of nature include, but are not limited to, animal sounds, such as whales singing or birds chirping; insect sounds, such as crickets; and sounds of the environment, such as a running stream or a waterfall.
• Sounds that have consistently soft dynamics with minimal melodic and harmonic variability, having little or no conventional beat pitch, little or no vocal, slow tempo, little or no percussion or strong rhythym are particularly effective in relaxing or soothing the user. Sounds that use a binaural beat created by using two pure frequencies, usually one in each ear, are useful in improving the mood of the user. Binaural beats in the frequency range of delta, theta and alpha brain wave frequencies are useful for relaxing the user and beats in the frequency range of beta wave activity are useful for promoting mental alertness in the user.
• the auditory stimuli may include, but are not limited to, a cassette tape, video tape, compact disc, interactive toys and games, websites, and a computer audio file.
• the visual stimuli may include, but are not limited to, soft lights, candles, videos, movies, paintings, murals, books, landscapes, interactive toys and games, websites, and computer image files that are soothing or relaxing to the consumer.
• the soft lights may be of any color, such as blue, green, pink, purple, and the like. Cool colors, such as blue and green hues, are preferred to soothe the user and aid relaxation; and warmer colors, such as oranges and reds are preferred to uplift the user. Pastel shades, which are low saturation hues, are useful in soothing the user.
• the light may be provided in the kit as a bulb, which can be inserted into a lamp at home, or may be provided in the kit as a lamp. Lights that utilize fiber optics may also be useful in the kits of this invention.
• the fiber optic lights may, as is known in the art, change colors intermittently. Soft lighting of approximately 500 lux is useful in relaxing the user, particularly in the evening hours prior to bedtime. Bright light of around 2000 lux or greater is useful in improving the mood of the user when used in the wakeful period of the day such as at awakening or any other time during the day prior to the few hours preceding bedtime.
• Combinations of light and sound that have frequency patterns in the range of delta, theta and alpha brain wave frequencies are useful for relaxing the user and those that have patterns in the frequency range of beta wave activity are useful for promoting mental alertness in the user.
• the tactile stimuli useful in the present invention includes, but is not limited to, computer software, interactive toys and games, bubble baths, lotions, and personal care compositions.
• Personal care compositions refers to personal cosmetic, toiletry, and healthcare products such as wipes, washes, baths, shampoos, gels, soaps, sticks, balms, sachets, pillows, mousses, sprays, lotions, creams, cleansing compositions, powders, oils, bath oils and other bath compositions which may be added to a bath.
• Personal care compositions may also include, but are not limited to, aerosols, candles, and substances that may be used with vaporizers.
• the aforementioned wipes, washes, baths, shampoos, gels, soaps, sticks, balms, sachets, pillows, mousses, sprays, lotions, creams, cleansing compositions, oils, bath oils, aerosols, candles and substances which may be used with vaporizers are commercially known to those who have a knowledge of preparing personal care compositions.
• One example of a suitable personal care composition is Johnson's Bedtime Bath®.
• the computer software may be of an interactive nature, such that the consumer relaxes while utilizing the software.
• Such software includes video games, crossword puzzles and the like.
• the method of the invention may include food and beverages, such as, but not limited to, fruits, candies, crackers, cheese, teas, and the like.
• the method of the invention may also include olfactory sensory experiences, such as fragrances. Fragrances that the user finds pleasant and to have a calming effect on their mood are useful in the practice of this invention. Suitable fragrances include relaxing fragrances, but are not limited to those perfume compositions described in UK application 0031047.4, now International Publication No. WO02/49600 Al, the disclosure of which is hereby incorporated by reference. Also suitable are the fragrances described in co-pending U.S. Patent Application Serial No. 09/676,876, filed September 29, 2000 entitled “Method For Calming Human Beings Using Personal Care Compositions", the disclosure of which is hereby incorporated by reference.
• the fragrance can be any fragrance that is perceivable and relaxing to the user and will downregulate the activity of the HPA axis.
• the stability of the fragrance in the presence of the anti- acne agent should be such that it remains perceivable and relaxing to the user.
• a daily regime may include a fragrance; soft light; bubble bath containing fragrance; and relaxing music.
• the fragrance may be sniffed intermittently during the day while sitting in a softly lit room and listening to the relaxing music.
• the bubble bath containing fragrance may be used in the morning or at night when bathing or showering while listening to the relaxing music.
• the sensory regimen is administered daily for at least one week and comprises smelling a relaxing fragrance while soaking in a bath and listening to relaxing music. Further benefits are noticed when the sensory regimen includes soft lighting as described above.
• anti-acne compositions useful in the methods according to the invention include compositions containing anti-acne agents known in the art.
• Suitable anti-acne agents include, but are not limited to, salicylic acid, sulfur, lactic acid, glycolic acid, pyruvic acid, urea, resorcinol, N-acetylcysteine, retinoic acid, benzoyl peroxide, octopirox, triclosan, azelaic acid, phenoxyethanol, phenoxypropanol, flavinoids, derivatives thereof, and combinations thereof.
• Benzoyl peroxide and salicylic acid are preferred anti-acne agents.
• anti-acne agents are used in amounts well known in the art for treatment of acne.
• salicylic acid is generally used in amounts ranging from about 0.5 to about 2% by weight of the composition.
• benzoyl peroxide it is generally present at from about 2.5% to about 10% by weight of the composition.
• antibacterial agents known to be useful for treating acne and other skin disorders can be incorporated into the anti-acne compositions in combination with the anti-acne agents described above.
• suitable antibacterial agents include, but are not limited to, erythromycin and clindamycin.
• the antibacterial agent is used in amount that is in accordance with the prescribed directions of the dermatologist.
• the anti-acne compositions are utilized as directed on the products, usually by topical application to the affected area several times daily.
• the effectiveness of the anti-acne composition is significantly improved through combining the use of sensory regimen with the topical application of the anti-acne agents.
• the administration of the above described sensory regimen in combination with the administration of the above described anti-acne composition can be used can be used to (1) reduce the number and severity of acne lesions on the skin of a mammal; (2) ameliorate the inflammation of acne lesions on the skin of a mammal; and (3) improve the skin tone of a mammal. Further, the reduction of acne, the amelioration of inflmmation of acne lesions and/or improved skin tone resulting from the inventive methods leads to an improved quality of life.
• the methods of the invention can be used for reducing stress and improving the emotional well being of an acne sufferer, the method comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition.
• the stress is chronic stress.
• the methods according to the invention can be used for the treatment of skin disorders.
• the method comprises the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an anti-acne composition, wherein said treatment comprises at least two of the following: (a) reducing the number and severity of acne lesions on the skin of a mammal; (b) ameliorating the inflammation of acne lesions on the skin of a mammal; and (c) improving the skin tone of a mammal.
• the methods according to the invention can also be used for the treatment of stress-related skin diseases selected from the group consisting of atopic dermatitis, sebhorreic dermatitis, psoriasis, itch, wound healing, fine lines, wrinkles, pigmentation, and combinations thereof, comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of said mammal in combination with the administration of an active agent.
• the stress- related skin disease is caused by chronic stress.
• the invention in another embodiment, relates to a method for reducing the visual appearance of shine on human skin comprising the step of administering a sensory regimen in an amount effective to downregulate the activity of the HPA axis of the human.
• a sensory regimen in an amount effective to downregulate the activity of the HPA axis of the human.
• Such a method may further comprise the administration of an anti-acne composition.
• the administration of the above described sensory regimen in combination with the administration of the above described anti- acne composition can be used can be used to reduce sebaceous gland output.
• the methods according to the invention can be used to increase compliance of the administration of anti-acne products.
• Benzoyl Peroxide Skin Cream #2 used by Group II was made by subtracting 0.2% water from the benzoyl peroxide skin cream #1 and replacing it with 0.2% fragrance (Quest PD-1861). On day one, the participants' faces were evaluated for severity of acne in terms of the number of lesions and the type of lesions present.
• the panelists in each group squeezed approximately a pea sized amount of the benzoyl peroxide skin cream into the palm of the hand and applied it to the entire facial area except eye, lip, and mouth areas. The panelists were not permitted to wash their faces for at least three hours after applying the cream.
• the product made my skin feel soft.
• the product was non-irritating to my skin.
• the product was quickly absorbed by my skin.
• the product did not make my skin flaky or have an ashy appearance.
• the product reduced my skin pore size.
• Group 3 applied the topical Benzoyl Peroxide Skin Cream #1 once per day, smelled a fragrance PD1861 supplied by Quest International while sitting and listening to relaxing music from the music CD entitled "Relax with Ocean Relaxing Surf by Eclipse Music Group for 10 minutes three times a day, and at night took a 35°C 15 minute bubble bath containing fragrance PD1861 supplied by Quest International.
• the sensory procedure schedule was as follows: session 1 was 10 minutes of music and fragrance 30 minutes after waking; session 2 was 10 minutes of music and fragrance 4 hours after waking; session 3 was 10 minutes of music and fragrance 8 hours after waking; session 4 was 15 minutes of fragranced bath and music 12 hours after waking (or just prior to bedtime). After one week and at the end of the two-week period, the participants were again evaluated for severity of acne. The results are shown in Tables 2 and 3.
• the data demonstrates that the number of inflammatory lesions is reduced through the use of a skin cream with an anti-acne agent in it.
• PD 1861 to the skin cream further reduced the number of lesions.
• the group that combined sensory experiences with the benzoyl peroxide skin cream demonstrated significant reduction in the number of inflammatory lesions after both the one and two week time points. Although, there appears to be less of a reduction in the total number of lesions after two weeks, it is important to note that inflammatory lesions are the most consumer noticeable symptom and product efficacy is often measured by the reduction in the number of inflammatory lesions.
• the scores for each question before the study were compared to the scores for the same questions after the study.
• the data is reported in Table 4 as percent of score improvement after treatment based on the average score for the entire group of participants. The statistical significance for the data is in parenthesis.
• Group 3 had a higher percent of participants feel better as a result of the treatment than any other group.
• the Group 3 participants had improved scores on the questionnaire than the other treatments. Positive effects from the combination of an anti-acne agent with a sensory regimen were seen symptomatically, functionally, emotionally, and on an overall basis.
• Group 5 smelled a fragrance PD1861 supplied by Quest International while sitting and listening to relaxing music from the music CD entitled "Relax with Ocean Relaxing Surf by Eclipse Music Group for 10 minutes three times a day, and took a 35°C 15 minute bubble bath at night containing fragrance PD1861 supplied by Quest International.
• the sensory procedure schedule was as follows: session 1 was 10 minutes of music and fragrance 30 minutes after waking; session 2 was 10 minutes of music and fragrance 4 hours after waking; session 3 was 10 minutes of music and fragrance 8 hours after waking; session 4 was 15 minutes of fragranced bath and music 12 hours after waking (or prior to bedtime).
• the placebo Group 4 clearly improved significantly in terms of reduction of inflammatory lesions. This is thought to be at least partially due to improved hygiene during the study, the consumer expectation of the "treatment", and potentially to the benzoyl peroxide Skin Cream #3 itself. This is somewhat shown by the fact that the use of the relaxation elements by themselves show dramatic reductions in the number of inflammatory lesions. It is important to note that the study in Example 3 was performed at a different time of the year than Examples 1 and 2, so the results of Example 3 should not be compared to the results of Examples 1 and 2. As with the data relating to inflammatory lesions, the data for reduction in total number of lesions also showed that both treatments were effective, with the benzoyl peroxide skin cream #3, being more effective.
• Group 5 had a decreased baseline cortisol level within one week, which lasted through the second week. This result correlated with the consumers' self -assessment, as well as the clinical data that was obtained.
• Group 4 (which had no inherent relaxation treatments beside the knowledge that the panelists were on a "treatment" study) showed a decrease in cortisol levels after one week. While a decrease was still seen after two weeks, the effect was not as sustained as was for Group 5 (having participated in the sensory regimen).

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• 2002
  • 2002-12-04 AU AU2002359599A patent/AU2002359599A1/en not_active Abandoned
  • 2002-12-04 JP JP2003550818A patent/JP2005517649A/ja active Pending
  • 2002-12-04 CN CNA028272994A patent/CN1615152A/zh active Pending
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  • 2002-12-04 EP EP02794147A patent/EP1474170A1/en not_active Withdrawn
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• 2008
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