A DEPIGMENTATION TOPICAL TREATMENT PROGRAM ENHANCES A PREVIOUS CHEMICAL PEELING OF THE FACE 391 subsequent acquisitions. An algorithm is then used to analyze the skin surface and mea- sure parameter changes versus baseline values. PRIMARY STUD Y END POINTS Skin hyperpi gmentation and texture were the primary effi cacy end points assessed in the study. A comparison between melanin concentration, pigment uniformity, and parame- ters inherent to the skin texture before and after the study treatment was made. SECONDARY ST UDY END POINTS Ease of use of the treatment. The ease of use of the hyperpigmentation topical treatment program was assessed through a fi ve-point questionnaire, where 1 = very simple, 2 = simple, 3 = neither simple nor complicated, 4 = complicated, and 5 = very complicated. The patients completed the questionnaires at the end of the study (visit 2). Pleasantness of the treatment. The pleasant ness of the three products constituting the hyper- pigmentation topical treatment program was assessed through three fi ve-point question- naires (one per product), where 1 = very pleasant, 2 = pleasant, 3 = neither pleasant nor unpleasant, 4 = unpleasant, and 5 = very unpleasant. The patients completed the ques- tionnaires at the end of the study (visit 2). Overall sati sfaction. The investig ator and the patients’ satisfaction with regard to the re- sults obtained after the treatment was assessed through two separate fi ve-point question- naires, where 1 = very satisfi ed, 2 = satisfi ed, 3 = neither satisfi ed nor dissatisfi ed, 4 = not satisfi ed, and 5 = very dissatisfi ed. The investigator and the patients completed the ques- tionnaires at the end of the study (visit 2). Safety and tolerability of the treatment . The safety profi le of the hyperpigmentation topical treatment program was assessed in terms of the number of AEs reported by the subjects or detected by the investigator. All the patients who received at least one application of one of the three products of the hyperpigmentation topical treatment program were included in the safety analysis. AEs were coded using the Medical Dictionary for Regulatory Activi- ties. The number of patients who experienced at least one AE, an AE related to the prod- uct, an SAE and the number of subjects withdrawn because of an AE are summarized. STATISTICAL ANALYSIS Data were analyzed using an intention-to-treat approach. The statistical analysis was car- ried out on patients who had completed study visits 1 and 2 (n = 16). Data were expressed as average, median, standard deviation, range for continuous variables, and as number of subjects and percentage values for categorical variables. T-tests for paired data were per- formed to assess whether changes versus the initial visits were statistically signifi cant. The signifi cance level of the statistical tests used was 5% the statistical tests that gave p values lower than 0.05 were considered statistically signifi cant. Where appropriate, 95% confi dence interval was calculated. Missing data were not replaced. Data were analyzed with SAS 9.4 software for Windows (SAS Institute Inc ., Cary, NC).

JOURNAL OF COSMETIC SCIENCE 392 ETHICS The clinical study was conducted in accordance with the ethical principles reported in the Declaration of Helsinki as amended by the World Medical Association in Fortaleza in 2013, in accordance with the Good Clinical Practice Guidelines and in compliance with Italian laws and regulations, including the General Data Protection Regulation and the Italian D. Lgs. 101/2018. RESULTS The study investigators assessed through the DACS the individual skin parameters (melanin concentration, pigment uniformity, and skin texture) at baseline (during study visit 1) and at the end of treatment (study visit 2). Individual data for skin parameters were available also for the prestudy period, that is, between the prepeel and study visit 1. The percentage changes in skin parameters between study visits 1 and 2 were described by mean, standard deviation, median, and minimum and maximum values. A paired t-test was performed to assess whether the changes versus baseline values measured at study visit 1 were statistically signifi cant. Baseline mean values in selected 56 × 56-mm skin areas were 0.62 for melanin concentration [standard deviation (SD) = 0.07, range: 0.50–0.74], 0.047 for pigment uniformity (SD = 0.011 range: 0.03–0.08), and 11.17 for skin texture (SD = 3.82 range: 6.62–20.29) (Table I). Prepeel mean values were 0.64 for melanin concentration (SD = 0.06, range: 0.52–0.75) and 10.80 for skin texture (SD = 4.24 range: 5.66–20.69). A comparison was made for each individual target skin area between the examination performed before and after the study treatment. T he mean melanin concentration at study visit 2 decreased to 0.59 (SD = 0.07, range: 0.48–0.70), with a mean of differences between study visits 1 and 2 of -0.03 (SD = 0.03, p = 0.0004). The individual measurement of melanin concentration at study visits 1 and 2 and the individual changes between the study visits (p 0.001) are shown in Figure 1. The mean pigment uniformity index at study visit 2 decreased to 0.044, with a mean of differences between study visits 1 and 2 of -0.003 (SD = 0.007, p = 0.1664). The mean skin texture index at study visit 2 decreased to 10.43, with a mean of differences between study visits 1 and 2 of -0.74 (SD = 1.92, p = 0.1456). Interestingly, the mean change of melanin concentration between the prepeel period and study visit 2 (prestudy + study period) was -7.8% (p 0.0001) (Figures 2 and 3). The e ase of use of the hyperpigmentation topical treatment program was rated through a fi ve-point questionnaire completed by the patients at study visit 2. The results were reported as number and percentage of patients for each point of the questionnaire. Fourteen patients (87.50%) evaluated the treatment as “very simple to use,” and two (12.50%) evaluated it as “simple to use.” The p leasantness of the three products constituting the depigmentation topical treatment program was rated through three fi ve point-questionnaires (one per product), completed by the patients at study visit 2. The results were reported as number and percentage of patients for each point of each questionnaire. All patients rated the use of the day cream as “pleasant” (56.25%) and “very pleasant” (43 .75%). Most pat ients rated the use of the night cream as “pleasant” (37.50%) and “very pleasant” (43.75%). Three patients (18.75%) rated the night cream use as “neither pleasant nor unpleasant” and two (12.50%)