INTRODUCTION. EADV 2015 poster 1044 (Pigmentary disease)

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1 Clinical and instrumental efficacy and tolerability of a dermocosmetic anti-aging and depigmenting serum 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 of a serum containing azelawhite complex (peptide 2%, azelaic acid 8%) and glycolic acid (3%) for photo-aged skin during 12 weeks. This association already demonstrated an anti-aging efficacy on human cutaneous explants*. The main objective was to evaluate the depigmenting and anti-aging effect of the serum on photoaging signs. Secondary objectives were to assess the tolerability and cosmetic acceptability of the serum. *Bacqueville D et al. Assessment of photo aging protection of the association of α-tocopheryl acetate, oligopeptide 68 and azelaic/glycolic acids in chronic UV-A radiation-exposed human skin model. SID LB767

2 METHODS 42 Caucasian volunteers (45-70 years, mean age 57 years) were includedand analyzed. At inclusion (D0), subjects presented periorbital wrinkles graded 3 to 6 (from 1 to 9 scale*) and at least one target facial lentigo. This serum was applied on face and neck twice daily (morning and evening), clinical and instrumental photo-aging signs assessments were performed : Assessment methods Clinical evaluation by a certified dermatologist on the target lentigo using the modified MASI score Instrumental assessment by chromametry (Angle ITA, Individual Typology Angle) Instrumental assessment by in vivo skin profiling (AEVA, Aging EVAluation) Instrumental assessment par cutometry Macroscopic high definition images of the target lentigo (DermLite) Clinical evaluation of tolerability (by a dermatologiste) Acceptability Questionnaire (for subjects) x x x *Fitzpatrick RE et al. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996;132(4):

3 RESULTS CLINICAL EVALUATION RESULTS modified MASI SCORE on target lentigo All subjects completed the study (n=42). The local MASI score for the target lentigo improved significantly after 4, 8 and 12 weeks of serum application (42,2% of improvement). Local modified MASI SCORE computing D x H (max score 20) Diameter (D) 0: Not measurable 1: 2 mm 2: 2-4 mm 3: 4-6 mm 4: 6-8 mm 5: > 8 mm Hyperpigmentation (H) 0: No H. 1: H. barely visible 2: H. slight 3: H. moderate 4: H. severe Modified MASI SCORE ,7 8,4 6,4 5,6-42.2%

4 DEPIGMENTING MEASUREMENTS Clinical results were confirmed by instrumental evaluation, with a significant increase of ITA values indicating a lighter color of the lentigo at each visit (p<0.001), as well as the color contrast (Delta E) analysis of the lentigo macroscopic images and on the surrounding skin (p<0.001). ITA ,5 ITA angle result (Chromametry) 37,8 37,5 39,7 Delta E D0 D28 D84 5 4,5 4 3,5 3 4,89 Delta E result (DermLite) 4,54 4,28 4,37 RESULTS Representative improvement of lentigo visibility displayed by DermLite camera in a 57 years old subject from inclusion to 84 days of product use

5 RESULTS «ANTI-AGING» MEASUREMENTS While an improvement of skin firmness or elasticity could not be shown (cutometer), AEVA assessment showed a significant improvement of the rough structures (deep wrinkles) after 4 weeks (p=0.008). P < AEVA Ra (Fine structures) and Rz (Rough structures) parameters Skin surface profile (µm) Skin elasticity D0 77,4 Fine lines reduction p = (SL) 171,2 Deep wrinkles decrease * p = (S) D28 74,6 161,1 Representative improvement of crow s feet wrinkles in a 46 years old subject from inclusion to 84 days of product use

6 RESULTS: Secondary objectives Tolerability: the serum was well tolerated (under dermatological control). Subjects Questionnaire: Since the 1st month, the efficacy related to the reduction of the photo-aging signs was perceived by the subjects and their satisfaction has increased during the study reaching 67 % after 12 weeks of product use. CONCLUSION The serum containing azelawhite complex and glycolic acid, applied twice daily on the face and neck in 42 women over a period of 12 weeks was well tolerated and considered efficacious to improve clinical aspect of photoage skin, both through dermatologist and noninvasive instrumental evaluation. therese.nocera@pierre-fabre.com Laboratoires Pierre-Fabre 2, rue de Viguerie Toulouse- France