BIOGOMM AGE. FM-097B Version 01 / /11

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1 FM-097B Version 01 / /11

2 Contents 1. Summary Natural skin desquamation process Cosmetic Exfoliation process: Indications Biogomm age s composition and description Ex vivo assessment of Biogomm age Materials and methods Results and discussion on ex vivo assessments Conclusion on ex vivo assessments Clinical investigation of Biogomm age Introduction Materials and methods of clinical tests Results and discussion Conclusions on clinical investigations General Conclusions FM-097B Version 01 / /11

3 1. Summary Biogomm age is a natural exfoliant composition developed by Induchem Companies from a vegetal sourcing. Biogomm age is composed of cellulose derived from soft wood). The present technical report contains ex vivo (human skin explant) and in vivo (clinical investigation on human volunteers) data related to efficacy and safety of the Biogomm age product. Biogomm age is more efficient (cleaner and softer skins) than apricot kernel particles without any drawbacks or side s effects (no scratching effect, no redness or irritation, no skin aggression). 2. Natural skin desquamation process The skin desquamation process is taking place in the stratum corneum. The building blocks of the stratum corneum, the corneocytes (dead cells), and their intercellular cohesive structures (corneodesmosomes), constitute an important part of the barrier. There is a continuous production of new stratum corneum. The turnover time of the stratum corneum is normally two to four weeks. As epidermis is constantly in selfrenewal, the superficial desquamation is adequately compensated by keratinocyte proliferation in epidermal basal layer. In order to maintain a constant stratum corneum thickness at a given body site superficial parts of the stratum corneum must be continuously shed in the process of desquamation at a rate, which balances de novo production of corneocytes. A central event in desquamation is elimination of corneocyte cohesion by degradation of corneodesmosomes by enzymes. The enzymes involved in desquamation were delivered into the intercellular spaces through the lamellar bodies. In physiological conditions, corneodesmosome degradation that leads to a controlled desquamation is a prerequisite to normal recycling of the stratum corneum and epidermal barrier function. Desquamation normally occurs invisibly with shedding of individual cells (corneocytes) or small aggregates of cells. Disturbances in this process results in the accumulation on the skin surface of only partially detached cells with or without a concomitant thickening of the stratum corneum. The accumulation on the skin surface of the cells and debris is combined with a feeling of roughness and dryness of the skin surface, to the accumulation of thick brittle scales such as in psoriasis or in the various forms of ichthyosis. 3. Cosmetic Exfoliation process: The skin of the human body periodically requires deep cleansing in order to remove there from sebaceous secretions, soil deposits and dead skin cells resulting from desquamation of the epidermal tissue. During natural desquamation process, skin can shed spontaneously 30,000 to 40,000 dead cells per minute; however, many people need exfoliation products to help reduce acne, psoriasis, ichthyosis and to get smooth and clean skin. Exfoliation is the cosmetic practice of removing dead skin cells and debris from the epidermis. Exfoliation can be accomplished by the use of a rough cleaning rag, a natural sponge or an exfoliant composition. Exfoliant compositions comprise an abrasive component to facilitate removal of the above-mentioned substances and debris. Exfoliative cleaning promotes regeneration of the epidermal tissue such that the skin regains suppleness and softness. FM-097B Version 01 / /11

4 Penetration of cosmetic is also facilitated by exfoliation. Known exfoliant abrasives include hydrogenated fats, inorganic salts such as sodium citrate or relatively low-molecular weight organics, such as sugars, synthetic polymers such as polyethylene powders and granulated particles or organo-polysiloxane, vegetable matter such as the endocarp of apricot, peach and walnut seeds, almond flesh, and wood flour. 4. Indications Biogomm ages can be used in various cosmetic products, essentially in two categories: Body care: body scrubs Face care: exfoliating gels, anti-aging exfoliating gels 5. Biogomm age s composition and description Composition or INCI name: Cellulose, Hydroxypropylcellulose. Dosage recommended: 3-5% Storage and shelf life: 5-25 C / 2 years Physical description: White or blue practically odourless powder Biogomm age range is preservative free. Biogomm age Series consists of two ranges: white range containing D-Panthenyl triacetate (WD) and blue range containing Tocopheryl Acetate (UE) (fig 1A). Each range is composed of three size fractions: WD1/UE1 with the size of µm; WD2/UE2 with the size of µm; WD3/UE3 with the size of µm. Table 1 is listing the available products and their parameters. A B Fig 1: Biogomm age references in a clear gel. Product reference Color Size (µm) White Blue BioGomm'age WD1 x x Biogomm'age WD2 x x BioGomm'age WD3 x x BioGomm'age UE1 x x BioGomm'age UE2 x x BioGomm'age UE3 x x Table 1: Biogomm age product range. FM-097B Version 01 / /11

5 Remark: During ex-vivo assessment and clinical investigation batches studied were not recorded under the reference products mentioned above in table 1. Ex-vivo study: Batch tested under the denomination W3 corresponds to the reference WD3. Clinical investigation: Batch tested under the denomination U2 corresponds to the reference UE2. The particle size distribution for each reference follows a Gauss distribution curve in accordance with internal quality specifications (fig 2). U1#or#W1# U2#or#W2# U3#or#W3# Fig 2: Distribution size of each range (Gauss curves) FM-097B Version 01 / /11

6 Vitamin E (tocopherol) has many biological functions, the antioxidant function being the most important and/or best known. Other functions include enzymatic activities, lipids protection. As an antioxidant, vitamin E acts as a radical scavenger, preventing the propagation of free radicals in tissues. Vitamin E also protects lipids and prevents the oxidation of polyunsaturated fatty acids. As it is fat-soluble, it is incorporated into cell membranes, which protects them from oxidative damage. An enzymatic activity regulator, for instance, protein kinase C (PKC), which plays a role in smooth muscle growth, can be inhibited by α-tocopherol. D-PTA (D-panthenyl triacetate) is a liposoluble derivative of Panthenol. D-PTA has similar properties to Panthenol. Panthenol is the alcohol analog of pantothenic acid (vitamin B5), and is thus a provitamin of B5. In organisms it is quickly oxidized to pantothenate. The D-panthenol (dexpanthenol) is the biological active form of the Panthenol. Dexpanthenol is widely used in medical products or medical device in skin repair, in nasal congestion, in occular treatment to help surgery. For irritated skin and nasal congestion treatment, Dexpanthenol is used for its soothing properties (reducing sensations of pain, burning, itching and discomfort) via its antioxidant and antiinflammatory action. 6. Ex vivo assessment of Biogomm age The aim of this ex vivo study was to explore the exfoliating property of Biogomm age on the human skin explants maintained in survival condition. The general morphology of the skin treated with Biogomm age in particular epidermis and stratum corneum was observed in comparison to Apricot Exfoliator. The Biogomm age references (W3) used for the study had the size of µm Materials and methods a. Human skin explants Human Skin explants were obtained from abdomino-plasty or mammal reduction from 6 healthy donors. b. Biogomm age treatments of skin explants Explants were either left untreated (control) or treated by gel with 5% Biogomm age W3 or with the reference product (Gel with 5% apricot exfoliator 500) at D0 and D1. The products after application are left on skin surface without any cleaning (to avoid stratum corneum shedding due to mechanical cleaning). The products were applied on days 0, and D1 in the mentioned concentrations topically on the basis of 2 mg per cm 2, using a small spatula. The culture medium was renewed at day 1. FM-097B Version 01 / /11

7 c. Histological analysis Preparation of explants for histological analysis: After treatment at D2, explants were fixed in buffered formalin. After the fixation in formalin, the samples were dehydrated and impregnated in paraffin. The samples were then embedded and sections were made using a microtome. The observation of the general morphology was performed after staining of formalin fixed and paraffinized sections by hemalun eosine. Grading of stratum corneum cohesion: The assessment of stratum corneum cohesion is directly related to exfoliation activity of the products. Based on skin histological sections, stained with hemalun eosin the anatomopathologist scored the stratum corneum cohesion following a specific grading: Score 0: no modification of stratum corneum cohesion Score 1: slight decrease of stratum corneum cohesion Score 2: moderate decrease of stratum corneum cohesion Score 3: important decrease of stratum corneum cohesion Score 4: very important decrease of stratum corneum cohesion Remark: The cohesion assessment was performed on the whole section (10 to 15 fields at the magnification 40 were analyzed) Results and discussion on ex vivo assessments Assessment of stratum corneum cohesion: A significant decrease in stratum corneum cohesion is seen in comparison to control skin (not treated) for both products tested (Gel with 5% Biogomm age W3 and Gel with 5% apricot exfoliator 500) see table 2. Type of condition assessed Stratum corneum cohesion score (average score) Control skin 1,7 ± 0,49 Skin + Gel with 5% Biogomm age W3 2,07 ± 0,45 * p = 0,003 Skin + Gel with 5% Apricot Exfoliator 500 2,10 ± 0,74 * p =0,045 Table 2: Histological assessment of stratum corneum cohesion (*: statistically significant difference in comparison to control skin (Student test, p < 0,05)). Histologically, no significant difference was seen between the test product (Gel with 5% Biogomm age W3) and the reference product (Gel with 5% apricot exfoliator 500) concerning their desquamation properties. Both products are moderate exfoliators with a more loosing stratum corneum in comparison to the skin untreated (narrowed stratum corneum)(see fig 3). FM-097B Version 01 / /11

8 Control skin Gel with 5% Biogomm age W3 Gel with 5% Apricot Exfoliator 500 Figure 3: Histological observation of skin untreated (control skin) and treated skin (Gel with 5% Biogomm age W3 and Gel with 5% Apricot Exfoliator 500) (Staining Hemalun Eosine, magnification X 40). Remark: The skins treated by exfoliator gels (Biogomm age and Apricot Exfoliator 500) were not rinsed after their application. If the skins were rinsed after application, the exfoliation of the stratum corneum will be more pronounced Conclusion on ex vivo assessments The ex-vivo investigations have shown that both products assessed are efficient exfoliators. The Gel with 5% Biogomm age W3 and Gel with 5% apricot exfoliator 500 have the same exfoliation power. 7. Clinical investigation of Biogomm age 7.1. Introduction First encouraging ex vivo results have shown the potential application of Biogomm age as exfoliating particles. To confirm its effectiveness as exfoliating particles a clinical investigation was performed with a gel containing Biogomm age. The following efficacy parameters of exfoliation were assessed based on: skin softness and skin cleanness. The tolerance parameters were the following: skin redness and skin irritation. These tolerance parameters were followed as the skin exfoliation process often impacts them Materials and methods of clinical tests a. Description of the formulations used: Gel formula containing apricot exfoliator (Reference BAE): Apricot kernel is a well know standard of exfoliation. Gel formula containing Biogomm age U2 (Reference BUD). b. Description of the panel and study condition: A panel test was run on 29 people, 20 of them being women, to evaluate and compare Biogomm age (reference BUD) to a reference apricot exfoliator (reference BAE). The study was simple blinded. Each tester used a gel containing 5% of Biogomm age U2 on one side of their face and a gel containing 5% of apricot exfoliator on the other side FM-097B Version 01 / /11

9 of their face. The volunteers were asked to massage their faces with light circular movements then wash the products with water. The products were used for one week at the testers' convenience as many times as desired. The methods used to assess the efficacy of the products are described in detail in the following sections. c. Efficacy assessment: Assessment of exfoliating properties (in use tests): The following criteria were assessed by questionnaire (self assessments): Skin softness sensation after washing Skin cleanness sensation after washing Product preference d. Safety assessment (Tolerance properties): The tolerance properties of the exfoliating product were assessed during in use tests by the following criteria (questionnaire): Sensation of skin aggression (feeling of scratches) by exfoliating particles Skin redness and slight irritation (after intensive use) 7.3. Results and discussion a. Efficacy assessment: Skin softness sensation after washing Type%of%product Number%of%volunteers %%of%volunteers Very%soft Soft No%difference Very%soft Soft No%difference BAE BUD Table 3: Skin softness assessment (Questionnaire) Both products assessed are efficient skin exfoliators. The product with Biogomm age (BUD) has shown the best efficacy in comparison to BAE product containing apricot kernels. 100% of the volunteers found their skins (soft or very soft) after the use of the product BUD. 97 % of the volunteers found their skins soft or very soft after the use of the product BAE. Remark: Two volunteers in the group were not able to evaluate the product BAE because it was too harsh for them. FM-097B Version 01 / /11

10 Sensation of cleaner skin after washing Type%of%product Number%of%volunteers %%of%volunteers BAE 9 31 BUD No%difference 9 31 Table 4: Skin cleanness assessment (Questionnaire) Most volunteers (38%) found their skins cleaner with the product BUD in comparison to the product BAE (31%). Product preference Type%of%product Number%of%volunteers %%of%volunteers BAE 6 21 BUD No%difference 0 0 Table 5: Product preference assessment (Questionnaire) The majority of the volunteers (79%) are satisfied by BUD product and preferred BUD product versus BAE product. The volunteers found that the product BUD was very easy to apply and to use. They are satisfied because they have a new experience sensation. The product is less aggressive for their skins with a high efficacy. b. Tolerance properties Sensation of skin aggression (feeling of scratches) by exfoliating particles: Type%of%product Number%of%volunteers %%of%volunteers BAE BUD 0 0 No%difference 0 0 Table 6: Assessment of skin sensation of aggression (Questionnaire) All volunteers (100%) felt scratching sensation of their skins with the product BAE. With the product BUD no aggression was felt. Skin redness and/or slight irritation (after intensive use) Type%of%product Number%of%volunteers %%of%volunteers BAE BUD 1 4 None 2 8 Both 1 4 Table 7: Assessment of skin redness and/or slight irritation (Questionnaire) Remark: 4 volunteers didn t answer to the question. FM-097B Version 01 / /11

11 8. Conclusions on clinical investigations The clinical investigation has shown that both products assessed are efficient exfoliators. Nethertheless, the cream containing 5% Biogomm age U2 is more efficient that apricot gel with less side s effects. Biogomm age U2 gel improved the following clinical parameters: Softness: Biogomm age U2 (100%) versus apricot exfoliator BAE (97%) Cleanness: Biogomm age U2 (38%) versus apricot exfoliator BAE (31%) Aggressiveness: Biogomm age U2 (0%) versus apricot exfoliator BAE (100%) Redness or slight irritation: Biogomm age U2 (0%) versus apricot exfoliator BAE (84%) 79% of the testers prefer gel with Biogomm age U2 versus the apricot exfoliator BAE. 9. General Conclusions Ex vivo experiments have shown the capabilities of Biogomm age to exfoliate skin in the same manner than a known reference product (5% Apricot Exfoliator gel 500). The clinical investigation performed on human volunteers confirms the efficacy of Biogomm age seen during ex vivo experiments. The clinical parameters are improved by Biogomm age treatment. Biogomm age exfoliates gently and efficiently the skin (clean and soft skin sensation) without any drawbacks or side s effects (no scratching effect, no redness or irritation, no skin aggression). All the volunteers prefer the Biogomm age gel versus the gel with apricot kernels. FM-097B Version 01 / /11