Clinical Studies and Safety Testing on SRCP Creams

The skin remodeling copper peptide creams come in many versions but in terms of their skin repair potential they are similar. Protect & Restore is formulated more for cosmetic uses and has a lighter color. Many women use it as a morning make-up base. BioHeal is designed more for therapeutic skin repair and is formulated with non-drug components (menthol and camphor) that help decrease pain and itching. Different versions of our SRCP creams were tested in the clinical studies and gave similar results on skin repair and reducing irritation.

UCSF Clinical Studies on Skin Regeneration with SRCP Creams

Jean-Auguste-Dominique Ingres - La Source

Skin Biology's skin creams are clinically-proven to stimulate skin regeneration in humans. Four independent, placebo-controlled double-blinded clinical studies at the University of California at San Francisco have given statistically significant positive results that our products markedly accelerated the rate of skin regeneration and reduced irritation after severe skin damage. Dr. Howard Maibach, who directed the studies, is one of the the world's leading dermatologists with over 60 books and over 1,350 papers on the topic.

During the studies, we actually tested three different skin repair creams in each study but published only the results on Protect & Restore. This allowed us to (1) determine the effect of different concentrations of copper-peptide in the creams (result - more peptide-copper produced more repair) , (2) determine the effect of different pain reducers such as camphor and menthol on healing (result - the pain reducers had no effect on skin repair), and (3) make small changes in the cream components that changed the viscosity of the creams (results - the changes had an insignificant effect on skin repair).

We tested our copper peptide products with meaningful skin regeneration studies. Many cosmetic studies report essentially meaningless studies on "reduction of fine lines and wrinkles". Plastic tapes or virtually any oily "goo" will give positive results on fine lines and wrinkle due to a temporary hydration of the skin's surface combined with a mild edema.

Dr. Maibach chose four types of skin damage to study.

1. Acetone damaged skin has had the fats removed from the skin and produces damage similar to a very dry and cracking skin.

2. Detergent damaged skin has many fats removed plus extensive damage to the outer layer of skin barrier proteins. The result is similar to putting your hands into soapy water for 24 hours.

3. Nickel allergy damaged skin is produced by the immune system and is similar to the skin damage caused by other allergic responses such as poison ivy, poison oak, and other allergens.

4. Tape stripped skin is similar to damaging scraps, abrasions, and small cuts on the skin's surface. A strip of tape is put on the skin, then quickly ripped off. This process is repeated about 50 times in the same place, ultimately producing a small wound in the skin.

UCSF Study - Acetone Damaged Skin

Publication by Zhai, Leow, and Maibach, "Human barrier recovery after acute acetone perturbation: an irritant dermatitis model", Clinical and Experimental Dermatology, Volume 23, pages 11-13, 1998.

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The skin repairing action of SRCP creams on skin damaged by the application of a fat solvent, acetone, was tested. The skin recovery is what would be expected by the use of the cream by a person with exceptionally dry and poorly moisturized skin.

The affected skin was treated daily with either a Skin Biology remodeling cream or a control placebo-cream (our basic cream but without our copper-peptide complex) for 5 days and skin repair was then monitored by computerized measurement of trans-epidermal water loss. The researchers wrote that "The topical agent (SRCPs) enhanced barrier recovery especially within the first 24 hours. (P<0.05)". This placebo-controlled double-blinded study gave statistically significant positive results as the SRCP cream accelerated the rate of skin repair. This acceleration of skin healing in normal healthy individuals is difficult to achieve.

Skin Recovery - Percent of Pre-injury Value

Time After Injury (Hours)	Control (No Treatment)	Placebo	SRCP Cream
24	17%	27%	43%
48	44%	45%	71%
72	61%	63%	77%
96	68%	68%	83%

UCSF Study - Detergent Irritated Skin

Publication by Zhai, Leow, and Maibach, "Sodium lauryl sulfate damaged skin in vivo in man: a water barrier repair model", Skin Research and Technology, Volume 4, pages 24-27, 1998.

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The skin repairing actions of SRCP creams on skin damaged by the application of an irritating detergent was tested. The detergent loosens the skin and breaks down the skin's natural barrier function. The skin recovery is what would be expected when the cream is used by a person whose skin has been exposed to skin-damaging irritants.

The affected skin was treated daily with either a Skin Biology remodeling cream or a placebo-cream (our basic cream without copper-peptide) for 5 days and skin repair was then monitored by computerized measurement of trans-epidermal water loss. The clinical investigators wrote that "The topical agent (SRCP Creams) produced a more rapid improvement in barrier function than the placebo vehicle, markedly accelerating repair at 48 hours. (P<0.01)" This placebo-controlled double-blinded study gave statistically significant positive results as the SRCP cream accelerated the rate of skin repair. This acceleration of skin healing in normal healthy individuals is difficult to achieve.

Skin Recovery - 100% before injury - 0% after injury

Time After Injury (Hours)	Control (No Treatment)	Placebo	SRCP Cream
24	-14% (worsened after injury)	-4% (worsened after injury)	1%
48	5%	21%	34%
72	35%	38%	49%
96	41%	43%	60%

UCSF Study - Nickel Allergy Skin Damage

Zhai, Chang, Singh, and Maibach, "In vivo nickel contact dermatitis: human model for topical therapeutics", Contact Dermatitis Vol. 40, pp. 205-208, 1999.

The number-one skin allergy is sensitivity to nickel. Approximately 25% of people have this allergy. The allergy comes from earrings and jewelry, belt buckles, industrial contact, and use of metal tools. The skin recovery is what would be expected when the cream is used by a nickel-sensitized person whose skin had been newly exposed allergy-causing irritants such as nickel, poison ivy or poison oak. The results suggest that the cream could be used in the place of skin-damaging cortisone.

The Skin Biology repair cream both accelerated the recovery of skin after injury and had an anti-inflammatory action on the skin of nickel-allergic persons who were exposed to nickel salts. The clinical investigators wrote that " The test topical agent (SRCP cream) was extremely effective in reducing the irritation in comparison to placebo control. In particular, the topical agent significantly accelerated the repair of skin, which was apparent in nearly all parameters on day 7, 9, and 10."

Both skin water loss and skin erythema (redness) were markedly reduced.

Skin Recovery 10 Days After Injury
(lower values are better)

	Control (No Treatment)	Placebo	SRCP Cream
Water Loss	1.0±0.2	0.9±0.2	0.4±0.1
Erythema	9.6±0.5	9.3±0.3	7.5±0.3

UCSF Study - Tape Stripped Damaged Skin

Zhai, Poblete, and Maibach, "Stripped skin model to predict irritation potential of topical agents in vivo in man", International Journal of Dermatology, Volume 37, pages 386-389, 1998.

Small wounds were created in skin by repeated tape-stripping to create minor skin wounds. Skin recovery was measured by the normalization of transepidermal water loss. The results compared untreated skin, a placebo cream (our basic cream without copper-peptide) and Protect & Restore.

The results indicate that the cream helps speed repair of minor skin injuries and skin wounds.

Skin Recovery (% of normal)

Time After Injury (Hours)	Control (No Treatment)	Placebo	SRCP Cream
24	24%	33%	37%
48	34%	50%	58%
72	47%	53%	62%
96	72%	70%	76%

Shanghai Medical Center Pilot Study on Psoriasis and Eczema

To:
Skin Biology

From:
Prof. DiJun Rong
Sectional Chief of Clinical Departments
Zhong Shan Hospital
Shanghai Medical University
Shanghai 200032, People's Republic of China

Re: Pilot Study of BioHeal

BioHeal cream was tested on four patients with chronic eczema and two patients with psoriasis. BioHeal was compared to a urea-based cream that was applied to lateral lesions on the same patient.

In the eczema patients, the cream was very effective in reducing the thickness and itching of the lesions. In the psoriasis patients, the thickness of the lesions was thinned significantly, itching was reduced, and the quality of the skin improved although pigmentation was unchanged.

There was no evidence of adverse actions of the creams on the skin and all blood and urine tests were normal.

Why SRCPs are Better than Cortisone on Irritated Skin

Skin Biology's skin remodeling copper peptide creams reduce the need for the use of corticosteroids for skin dermatitis. Corticosteroids (such as cortisone) produce damaged and thinned skin (often 50% thinner) by inhibiting the natural skin repair processes. Use of corticosteroids produces a vicious cycle requiring more corticosteroid use due to more irritations from the weakened skin. The use can promote diabetic conditions, thymus involution, immune suppression, the spread of cancers, bone damage, and cataracts. It is estimated that 5,000 hip replacements yearly in Canada are due to overuse of corticosteroids.

During inflammation, the skin is damaged by immune cells that release toxic oxygen radicals into the damaged area. The purpose of these oxygen radicals is to kill invading bacteria after wounding but often the oxygen radicals are released in the absence of any bacteria. Cortisone and corticosteroids act by killing the immune cells to stop oxygen radical release but this also kills the immune cells that release the skin repair growth factors and hence stops skin repair which ultimately leads to a thinned and damaged skin.

Copper-peptides, on the other hand, directly detoxify the oxygen radicals. They also transfer copper to superoxide dismutase (SOD), the skin's primary anti-oxidant protein, which activates more of the skin's SOD (normally only about 30% of SOD is active) which further increases the removal of oxygen radicals. Also, the copper-complexes have been shown to strongly stimulate the skin's repair systems and improve healing and skin renewal. The above mentioned nickel allergy study demonstrated both the anti-inflammatory and skin repair properties of copper-peptides1.

	SRCP Creams	Cortisone and Other Corticosteroids
Stops Inflammation By	1. Detoxifying oxygen radicals 2. Activating the skin's superoxide dismutase	1. Killing immune cell macrophages and neutrophils which secrete oxygen radicals
Effect on Skin Repair and Renewal	Strongly stimulates skin repair and renewal	Stops skin repair and renewal by killing macrophages which secrete skin repair growth factors

Anti-Bacterial Properties of SRCP Creams

Tests on Skin Biology's SRCP creams by BioResearch Labs (Redmond, WA) detected no bacteria in the creams after incubation in bacterial growth media at 37 degrees centigrade for one week. When the cream was applied to cultures of pathogenic microorganisms found in infected wounds, it was found to strongly inhibit the growth of pathogenic bacteria common to wounds, Staphylococcus epidermidis, Streptococcus faecalis, and Pseudomonas aeruginosa.

Safety Testing on SRCP Creams

Jean-Auguste-Dominique Ingres - Half Figure of a Bather

Cosmetics without rigorous safety testing only put your personal health at risk. Skin Biology's SRCP creams have passed numerous safety tests at the University of California at San Francisco (UCSF) and at the Shanghai Medical University. SRCP creams have been found to be non-irritating and safe. Protect & Restore (1) was non-irritating by the human patch test (5 days of heavy covering of product on the skin), (2) was non-irritating on tape-stripped (injured) human skin, (3) passed the Ames (bacterial) test for carcinogenicity, (4) passed the guinea pig acute skin irritation test and was classified as a non-irritant, (5) passed the human induced-allergy test and classified as a non-allergen, (6) was non-comedogenic in humans and (7) was found have no evidence of oral toxicity in mice.