JOURNAL OF COSMETIC SCIENCE 388 The Defi nisse Peel Program includes a fi xed-dose combination of salicylic acid, pyruvic acid, and retinoic acid, with the integration of the depigmentation agents Lumiskin™ (diacetyl boldine, a tyrosinase inhibitor) (Sederma, Le Perray-en-Yvelines, France) and SEPIWHITE™, containing lipoaminoacid (undecylenoyl phenylalanine) (Seppic SA, Paris, France). EXCLU SION CRITERIA The s tudy exclusion criteria were pregnancy delivery during the last 30 d current in- fl ammatory and infective skin diseases current topical facial treatment with exfoliating, depigmenting products or topical/systemic use of antibiotics and photosensitizing drugs skin phototypes IV-V according to Fitzpatrick classifi cation cognitive impairment or any other condition or a condition that, according to the investigators, made possible a poor adherence to required procedures planned for the entire study duration any disease or skin condition or other body condition that, according to investigators’ judgment, could place the subject at risk if participating in this study or might interfere with study assess- ments skin exposure planned during the study period or exposure to ultraviolet rays or use of self-tanning products known intolerance to one or more components of the inves- tigational products and prior participation in this study. PANEL COMPOSITION In th is clinical study, 20 women with acquired hyperpigmentation who had undergone a chemical peeling treatment with a superfi cial chemical peel (Defi nisse Peel Program) in- cluding a fi xed-dose combination of salicylic acid, pyruvic acid, and retinoic acid for facial skin defects such as melasma, skin spots, postinfl ammatory hyperpigmentation, photoaging, and chronoaging were evaluated for enrollment. No sample size calculation was performed. The investigator obtained the informed consent from each patient before the inclusion in the study, in accordance with the International Conference on Harmonisation- Good Clinical Practice Guidelines and the Declaration of Helsinki. Sixteen of the 20 women satisfi ed both the protocol inclusion and exclusion criteria described previously and were selected for study participation (mean age: 53 years, range: 23–77 years). Patients’ demo- graphic data are summarized in Table I. PROTO COL At st udy visit 1, after eligibility confi rmation, all patients received the hyperpigmenta- tion topical treatment program products to start the home-based treatment immediately. The study participants were instructed to apply at home the study products every day for 30 d, as detailed in the “Products” section. After that, a fi nal visit (end of treatment/end of the study) was performed 30 d later (visit 2). Pregn ancy tests and clinical analysis were performed for participants of childbearing potential or to check that their medical history did fi t the inclusion/exclusion criteria (Table I). All th e subjects attended two study visits: initial visit-T0-day 1 (visit 1) and fi nal visit-T1-day 31 (visit 2). The products in this open-label study were applied daily from day 1 to day 30. During study visit 1, the written consent for study participation and personal data processing was obtained, and data collection and tests were initiated to

A DEPIGMENTATION TOPICAL TREATMENT PROGRAM ENHANCES A PREVIOUS CHEMICAL PEELING OF THE FACE 389 verify the fulfi llment of the study inclusion/exclusion criteria listed previously. A clinical and instrumental evaluation of skin quality and degree of skin pigmentation using the digital analysis of cutaneous surface (DACS) was performed. Durin g study visit 2, the following procedures were completed for each study subject: clinical and DACS-mediated evaluation of skin quality and degree of skin pigmentation recording of any changes in concomitant treatments recording of any adverse event (AE) or serious AE (SAE), with particular attention to those that could have occurred in the treated areas (e.g., burning, redness, and itching) collection of unused (or partially used) study products and verifi cation of their use made by the subjects completion by the inves- tigator of the questionnaire on treatment satisfaction and compilation by the subjects of the questionnaires on treatment satisfaction and on the pleasantness and ease of use of the hyperpigmentation topical treatment program. The 1 6 study participants were suffi ciently compliant with the prescribed treatments, and none of them dropped out prematurely. No AEs or SAEs were reported during the study. Local tolerability of the three components of the hyperpigmentation topical treat- ment program was assessed by the study investigators, and no safety concern was issued. Prima ry study end points were hyperpigmentation reduction and change in skin texture induced by the investigational product applied for 30 d after a chemical peeling. The reduction of hyperpigmentation and the changes in skin texture were assessed by instru- mental tests (DACS), described in more detail in the following texts (19–22). Because the study product was intended for at-home administration, the study included as secondary end points the ease of use of the treatment, its pleasantness, the overall satisfaction of patients and study investigators, and the safety and tolerability of the treatment. Table I Patients’ Demogr a phic Data and Baseline Values for Skin Parameters Parameter Statistics/categories Pigment solution (N = 29) Age (years) N 16 Mean (SD) 52.75 (11.40) Median 51.00 Minimum/maximum 28.00/77.00 Medical history [N (%)] No 9 (56.25%) Yes 7 (43.75%) Product used for peeling [N (%)] Lightening peel 16 (100.0%) Pregnancy test [N (%)] No 9 (56.25%) Yes 7 (43.75%) Negative 7 (100.0%) Melanin concentration N 16 Mean (SD) 0.62 (0.07) Median 0.64 Minimum/maximum 0.50/0.74 Skin texture N 16 Mean (SD) 11.17 (3.82) Median 10.8 Minimum/maximum 6.62/20.29 Pigment uniformity N 16 Mean (SD) 0.05 (0.01) Median 0.05 Minimum/maximum 0.03/0.08