A DEPIGMENTATION TOPICAL TREATMENT PROGRAM ENHANCES A PREVIOUS CHEMICAL PEELING OF THE FACE 387 epidermis and dermis stimulated by a controlled infl ammatory reaction, with the synthe- sis of new c ollagen and a more evenly distributed melanin (15,17). Chemical peels are effective in improving skin tone and reducing melanin concentration. However, outpatient chemical peels can be combined with other home-based treatments to provide a synergis- tic approach and optimize clinical outcomes, enhance patients’ satisfaction, and allow clini- cians to tailor the treatment to individual patient needs and conditions (15,18). In particular, Rendon et al. (15) reviewed several chemical peel protocols applied to melasma, including those based on glycolic acid and salicylic acid, and concluded that a maintenance therapy is needed when peeling is used for melasma, and that chemical peels may be most effective when used in combination with medical therapy or other procedures possibly because peels remove melanin, although other treatments inhibit melanocytes or melanogenesis. C hemical peeling treatments can be classifi ed into three categories: superfi cial peels, which exfoliate the epidermal layers without going beyond the basal layer medium depth peels, which reach to the upper reticular dermis deep peels, which penetrate the lower reticular dermis (18). The depth of peeling, and thus the degree of its therapeutic effects, is affected by different factors, including the properties of the chemical agents used (e.g., concentration and pH), the application technique, and the skin condition and sensitivity. O nce a chemical exfoliant has exhausted its thinning action on epidermal structures, the depigmentation process does not continue further and can be considered stabilized. How- ever, its benefi cial action could be potentiated by subsequent dermocosmetic treatments. Here, we report the results of a monocentric, prospective, noncontrolled study carried out in female subjects submitted to chemical peeling within 7 d before the study inclusion and aimed at the evaluation of the effects of a 30-d topical, depigmenting dermocosmetic treatment program on facial hyperpigmentation, pigment uniformity, and skin texture. M ETHODS S TUDY DESIGN T his was a monocentric, prospective, noncontrolled study carried out between December 2018 and February 2019 (fi rst s ubject enrolled and last subject completed) in Milan, Italy, aimed at the evaluation of the effi cacy, safety, ease of use, pleasantness, and tolerability of a depigmenting topical dermocosmetic treatment program in the reduction of facial hyper- pigmentation, measured as dark spot size reduction, in subjects submitted to chemical peeling within 7 d before the study inclusion. T he protocol, consent form, information sheet, and any written information to be provided to study participants were submitted to an independent ethics committee, and a copy of the written approval was obtained. The study was conducted in accordance with the Italian regulations and requirements. I NCLUSION CRITERIA T he study inclusion criteria were signed informed consent, ≥18 years of age, a good general health condition, and superfi cial depigmenting chemical peeling treatment within 7 d before the study enrollment with the Defi nisse™ Peel Program (Mastelli Srl, Sanremo, Italy).
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
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