Nocera T (1,2), Lapalud P (1), Touitou K (3), Rossi AB (1,2) INTRODUCTION

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1 Clinical and instrumental efficacy and tolerability of a dermo-cosmetic depigmenting and anti-aging night care on reducing actinic lentigo and wrinkles Nocera T (1,2), Lapalud P (1), Touitou K (3), Rossi AB (1,2) 1 Clinical Skin Research & Development Center, Hôtel Dieu Toulouse, Pierre-Fabre Dermo-Cosmétique, France; 2 Department of Dermatology, University Hospital Toulouse, France; 3 Product Development Department Center, Castanet-Tolosan, Pierre-Fabre Dermo-Cosmétique, France. INTRODUCTION The aim of this monocentric open-label clinical study was to assess the clinical and instrumental efficacy and tolerability in use conditions during 8 weeks of a night care containing uniwhite peptide (2%), niacinamide (4%), vitamin C derivative (4%) and hyaluronic acid (0.1%) for photo-aged skin. The main objective of this study was to evaluate the depigmenting and anti-aging effect of the night care on photo-aging signs. Secondary objectives were to assess the tolerability and cosmetic acceptability of the night care.

2 METHODS 46 Caucasian volunteers (53-70 years) were included and analyzed. At inclusion (D0), subjects presented crow s foot wrinkles graded 2 to 6 (from photo-grading scale 0 to 8) and at least one target lentigo. The product was applied on face and neckline each evening; clinical and instrumental photo-aging signs assessments were performed : Assessment methods D0 D28 D56 Clinical evaluation by a trained expert on digital photographs (4 parameters) Analysis of dark spots and melanin on digital photographs Expert in vivo clinical evaluation (4 parameters including crow s foot wrinkles grading) Clinical evaluation of skin and eye tolerability (by a dermatologist and ophtalmologist) x x x x x x x x x x x X Self evaluation questionnaires x x

3 All subjects completed the study (n = 46) mean age 64 years. Results from clinical evaluation on digital photographs showed significant improvement of skin complexion (homogeneity and brightness) with a lightening effect of the product, and increase of the lentigo ranking indicating a decrease of the lentigo visibility at each visit (p<0.001). D0 D28 D56 Clinical Evaluation On Digital Photographs Mean variation Ranking 1,4 1,2 1 0,8 0,6 0,4 0,2 0 *S for all comparison analysis p <0.001 complexion homogeneity 0,1 lentigo ranking lightening effect face complexion 0 0,5 0,6 0,4 METHODS OF PHOTOGRAPHS RANKING 1,1 D0 D28 D56 RESULTS 0,5 Descriptor Correspondence Associates effect of expected No photo difference Difference 1 photo vs 2 others The 3 are different Mark 0 for all photos Mark 1 for the best Mark 2 : the best Mark 1 : average Mark 0 : the worst If increase of ranking: - Skin complexion - Lightening effect - Complexion brightness - Lentigo visibility Digital photographs ¾ bench (56 years old subject) at D0, D28 and D56

4 Dark spot analysis DEPIGMENTING EFFECT ASSESSMENT RESULTS Software analysis (n=39) showed a significant decrease of the color contrast between lentigo and surrounding skin (up to 20% of improvement at D28), and target area indicating a depigmenting effect on lentigo until D56 (p<0.005). *for all comparison analysis Area ΔE*ab Variation vs D0 (%) ,4-13,2 Melanin analysis -20,1 S*, p < ,1-14,3-18,1 (D28 - D0)/D0 (D56 - D0)/D0 Sharpness (ITA variance) Results were confirmed by melanin analysis, with a significant decrease in melanin component at each visit (p < 0.001) showing a lightening effect of the product (mean percentage improvement of 5,5% from the 1st month). D0 D56 Representative macroscopic images of a target lentigo of a 63 years old subject at DO and D56 D0 D56 Melanin mapping (56 years old subject), D0 vs D56

5 ANTI-AGING MEASUREMENTS RESULTS In vivo evaluation of 4 parameters (photo-grading scale for crow s foot wrinkles and visual analogic scales for the 3 others) performed by an expert showed a significant improvement of skin luminosity and complexion homogeneity, increasing at each visit, and a decrease of crow s foot wrinkles depth. In vivo evaluation Skin luminosity Complexion homogeneity Mean variation of ranking (scale score) Nourished skin Crow s foot wrinkles grade RESULTS: Secondary objectives Tolerability: The night care was well tolerated (under dermatological and ophtalmological control). Subjects Questionnaire: Since the 1 st month, 80 % of subjects considered that the product had a redensifying effect and 91% felt a deeply nourrished skin.

6 CONCLUSION The night containing peptide, niacinamide, ascorbic glucoside and hyaluronic acid, when applied once-daily on the face and neck in 46 women (mean age 63 years) over a period of 8 weeks, was well tolerated and effective to improve clinical aspects of photo-aged skin, as lentigos and face wrinkles, both through clinical in vivo and non invasive instrumental evaluation. therese.nocera@pierre-fabre.com Laboratoires Pierre-Fabre 2, rue de Viguerie Toulouse- France

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