Sanicapyl. by Beauty Creations. For scalp health & hair beauty

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1 Sanicapyl by eauty Creations For scalp health & hair beauty

2 How to overcome dandruff conditions and scalp oiliness while beautifying hair? Oily dandruff conditions are mainly linked to excess production of sebum, exacerbated by hyperkeratosis and bacterial overproliferation. Associated inflammatory problems generate sensations of discomfort and itching, leaving hair shafts weakened and dull. Existing treatments are generally extremely effective in reducing dandruff but have a low impact on regulating sebum production. Itching persists while hair remains dull and lackluster in appearance. Synthetic molecules are most effective when it comes to deep-cleansing the scalp, but naturally provided effectiveness has real market value. This is why we have developed Sanicapyl, a natural complex that works in many ways to ensure scalp comfort and hair beauty with perceptible and visible results (proven by in vitro and in vivo tests vs. benchmark active ingredients). 1) Treatment for a purified, relaxed scalp (perceptible wellness effect): - visible dandruff-reducing action, - deep-down purifying action: inhibiting microbial proliferation and reducing sebum rate, - soothing action: anti-inflammatory, significant reduction in sensations of itching, - moisturizing action: preserving the cutaneous barrier function for optimal protection. 2) Hair beautifying treatment without a weighing-down effect (visible appeal): - reveals radiance, - boosts softness.

3 Definition / Composition Sanicapyl LS9863 is a natural complex made with: - Extract of Piper nigrum berries (black pepper) titrated in piperine. Anti-inflammatory and soothing properties. - Extract of Inga alba barks: a tree growing in French Guyana and mainly used for body massages and for the treatment of skin damage. Moisturizing properties and protection of the cutaneous barrier function. - Sodium Lauroyl Lactylate: derivative of botanical origin. Cleansing and purifying properties. Hair benefits Perceptible action on the scalp: - dandruff reduction, - sebum regulation, - reduced sensations of discomfort such as itching, - hydration, - soothing and purifying power. Visible action improving hair radiance and sensory properties: - shine, - softness, - easy styling. Cosmetics use Rebalancing scalp care. Treatment for dandruff prone scalp. Hair beautifier. Suitable for all hair types. Compatible with shampoo, conditioner and lotion formulas. Dosage / Solubility / Mode of incorporation 1. Dose of use: 0.3 to 1%. 2. Solubility: soluble in water, insoluble in oils and fats. 3. Mode of incorporation: Sanicapyl must be incorporated at a temperature below or equal at 40 C during the final process. Compatible with cold formulations. Optimal ph: between 4 and 7 Analytical characteristics 1. Aspect: amber liquid, weak odor. 2. Specifications: upon request. 3. Preservative: no. Toxicological data On request. Efficacy Efficacy tests hereafter. Storage In its original packaging, at C. Regulatory data Sanicapyl LS9863 INCI name (US): Sodium Lauroyl Lactylate (and) utylene Glycol (and) Piper Nigrum (Pepper) Fruit Extract (and) Inga Alba ark Extract INCI name (EU): Sodium Lauroyl Lactylate (and) utylene Glycol (and) Piper Nigrum Fruit Extract (and) Inga Alba ark Extract CAS: , , , EINECS: , , , /

4 Anti-microbial activity (in vitro test) Aim To evaluate the anti-microbial activity of Sanicapyl against the bacterial strains (Malassezia globosa and Malassezia furfur) present on hair scalp and responsible for dandruff, inflammation and irritation. Protocol Determination of Minimum Inhibitory Concentration (MIC) using agar dilution method. MIC corresponds to the lowest test substance concentration that completely inhibits the growth of tested microorganism. Incorporation of Sanicapyl into agar medium in a concentration range between 0.004% and 2.0%. Inoculation of microorganism and incubation for 48 hours at 30 C. MIC reading after 48 hours. Final concentration of Sanicapyl (%) Malassezia globosa CS 7874 Malassezia furfur DSM MIC (%) Conclusion A strong anti-microbial activity on Malassezia globosa and Malassezia furfur can be concluded for Sanicapyl. Anti-inflammatory activity (in vitro test) Aim To evaluate the anti-inflammatory activity of Sanicapyl on human keratinocytes on the model of UV induced inflammation. Aspirin, an inhibitor of cyclooxygenase activity, was used as positive control. Protocol Seeding of human keratinocytes in growth cell culture medium Incubation for 3 days at 37 C, CO 2 = 5% and 95% of relative humidity Replacing growth cell culture medium by balanced salt solution (Hank s solution) containing the products then irradiation by UV at 50 m/cm² Control Aspirin SANICAPYL Incubation for 1 day at 37 C, CO 2 = 5% and 95% of relative humidity Measurement of viable cells (MTT test), lactate dehydrogenase (LDH) and prostaglandin E2 (PGE2) Fig. 1 - Schema of protocol. Sanicapyl has not influenced the effect of UV on cell viability, but it has significantly decreased the levels of released LDH and PGE * * * * * Cell viability LDH PGE2 Control without UV UV at 50 m/cm² UV + aspirin at 0.03% UV + Sanicapyl % UV + Sanicapyl % UV + Sanicapyl 0.001% Mean ± SEM on 3 assays in triplicate Student s t test (*) p<0.05 () p<0.01 Fig. 2 - Protection of human keratinocytes from UV induced inflammation. Conclusion Sanicapyl has significantly and in a dose-dependent way reduced the release of LDH (marker of cell necrosis) and PGE2 (marker of inflammation).

5 Moisturizing activity (in vitro test on human horny layer) Aim To evaluate the moisturizing activity on stratum corneum in vitro of Sanicapyl by measurement of the dielectric conductivity. Protocol Human skin Stratum corneum 44% RH Conductivity measurement before treatment Treatment Control without treatment Treatment with placebo hydrogel Treatment with hydrogel with 2% glycerin Treatment with hydrogel with 2% SANICAPYL Fig. 3 - Schema of protocol. Dose 1 mg/cm² 3 times in 60 minutes (0, 30 and 60 minutes) Conductivity measurement up to 24 hours The increase of dielectric conductivity after the treatment with hydrogels containing either 2% glycerin (positive control) or 2% Sanicapyl was significantly superior to placebo hydrogel. Dielectric conductivity (µs) efore 0.5 hour 1 hour 2 hours 4hours 6 hours 24 hours Control Placebo hydrogel Hydrogel with 2% glycerin Hydrogel with 2% Sanicapyl Mean ± SEMon 10 assays 1 factor ANOVA A posteriori test: PLSD of Fisher () Significant / control & placebo Fig. 4 - Moisturizing activity of Sanicapyl evaluated by measurement of dielectric conductivity on the human horny layer in vitro at 44% relative humidity. Conclusion Long lasting moisturizing efficacy on scalp can lead to regulation of desquamation and preservation of the skin barrier.

6 Improvement of the scalp and hair properties (clinical test) Aim To evaluate, in vivo, the improvement of scalp conditions (dandruff, sebum) of a shampoo with 1% Sanicapyl against a shampoo with 1% zinc pyrithione, after 4 weeks of treatment and 2 weeks of remanence period. Protocol Human volunteers presenting dry or greasy dandruff (dandruff degree 2) Treatment: D-14 to D0 Wash out period = treatment with shampoo without active ingredient (base) under normal use condition (3 times/week) D0 to D28 Treatment with shampoo containing either 1% of SANICAPYL or 1% of zinc pyrithione under normal use condition (3 times/week) D28 to D42 Remanence period = same treatment as Wash out period Evaluation by trained panelists Quantification of dandruff by Corneofix Values between 0 (absence) and 4 (very abundant) Quantification of sebum secretion by Sebufix 0 is equivalent to 0-50 µg/cm² of sebum in Sebumeter, 1 to 51 - µg/cm², 2 to µg/cm², 3 to µg/cm², 4 to µg/cm², 5 to >250 µg/cm² D0, D28, D42 Subjective questionnaire D42 Fig. 5 - Schema of protocol. Reduction of dandruff Significant reduction of dandruff observed after 28 days of treatment (D28) comparatively to before treatment (D0) for Sanicapyl at 1%, was maintained also after the 14 days of remanence period (D42). The anti-dandruff activity of Sanicapyl was comparable to the activity of zinc pyrithione at 1%. Corneofix scoring at D0, D28 and D Treatment period Remanence Treatment period Remanence Shampoo with 1% zinc pyrithione Shampoo with 1% Sanicapyl 2 * * 1.5 Mean ± SEM 1 * on 14 volunteers (zinc pyrithione) or 25 volunteers (SANICAPYL ) 0.5 Student s t test () p< (*) p<0.001 D0 D28 D42 D0 D28 D42 Fig. 6 - Dandruff quantification: Corneofix scoring by trained panelists. Reduction of sebum Significant diminution of sebum secretion was observed for the shampoo containing 1% Sanicapyl, after the remanence period (D42). etter efficacy than zinc pyrithione at 1%. Sebufix scoring at D0, D28 and D Treatment period Remanence Treatment period Remanence ns D0 D28 D42 D0 D28 D42 Fig. 7 - Sebum secretion: Sebufix scoring by trained panelists. ns Shampoo with 1% zinc pyrithione Shampoo with 1% Sanicapyl Mean ± SEM on 14 volunteers (zinc pyrithione) or 25 volunteers (Sanicapyl ) Student s t test (NS) Not significant / D0 ( ) p<0.1 () p<0.01

7 Subjective questionnaire The positive appreciation of evaluated cosmetic properties for formulation with Sanicapyl was superior comparatively to the zinc pyrithione formulation. S C A LP Reduction of the shampoo frequency Reduction of the dandruff Elimination of the dandruff Shampoo with 1% zinc pyrithione Shampoo with 1% Sanicapyl H E A L T H Suits to hair type Hair looks healthier Reduction of the itching sensation Immediately efficient Percentage of response «Agree-partially agree» H A I R E A Convenient for frequent use Softness on dry hair Cleansing and manageability Anti-seborrheic Softness on wet hair U TY Improvement of hair radiance Facility of combing Shampoo with 1% zinc pyrithione Fig. 8 - Subjective questionnaire: cosmetic and sensorial properties on scalp and hair. Conclusion Sanicapyl has presented a significant improvement of the scalp conditions (reduction of dandruff state, sebum production and sensation of itching) as well as a visible action on hair beautifying (hair radiance and softness).

8 EUROPE ASF eauty Creations 49, avenue Georges Pompidou Levallois-Perret Cedex France Tel: +33 (0) Fax: +33 (0) AMERICAS eauty Creations ASF Corporation 50 Health Sciences Drive Stony rook, NY USA Tel: +1 (631) Fax: +1 (631) APAN & ASIA-PACIFIC ASF apan Ltd. 21F Roppongi Hills Mori Tower, Roppongi, Minato-ku, Tokyo, APAN Tel: +81 (0) Fax: +81 (0) Edition Septembre 13, 2012 Although all statements and information in this publication are believed to be accurate and reliable, they are presented gratis and for guidance only, and risks and liability for results obtained by use of the products or application of the suggestions described are assumed by the user. THERE ARE NO WARRANTIES OF ANY KIND. ALL EXPRESS AND IMPLIED WARRANTIES ARE DISCLAIMED. Statements or suggestions concerning possible use of the products are made without representation or warranty that any such use is free of patent infringement and are not recommendations to infringe any patent. The user should not assume that toxicity data and safety measures are indicated or that other measures may not be required. The claims and supporting data provided in this publication have not been evaluated for compliance with any jurisdiction s regulatory requirements and the results reported may not be generally true under other conditions or in other matrices. Users must evaluate what claims and information are appropriate and comply with a jurisdiction s regulatory requirements. Recipient of this publication agrees to (i) indemnify and hold harmless each entity of the ASF organization for any and all regulatory action arising from recipient s use of any claims or information in this publication, including, but not limited to, use in advertising and finished product label claims, and (ii) not present this publication as evidence of finished product claim substantiation to any regulatory authority.

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