Clinical efficacy and tolerability of a hydroquinone-free and retinol-free topical brightening serum on females with facial melasma
Presenters: Makino ET, Tan P; Mehta RC
Affiliation: Research & Development SkinMedica, an Allergan Company, Irvine, CA
Background/Objective: Melasma, a progressive form of hyperpigmentation, occurs more often in healthy women than men. The actual etiology is indefinite; however, pregnancy, hormonal changes, ultraviolet (UV) light exposure, photosensitizing medications, and genetic predisposition have all been considered as contributing factors. This dysfunction of the pigmentary system results in symmetric brown or gray-brown patches on sun exposed areas of the face, particularly on the forehead, cheeks, upper lip, and chin. Often, the psychosocial impact of melasma leads to a negative effect on quality of life and emotional well-being. The purpose of this study was to assess the cosmetic efficacy and tolerability of a HQ-free and retinol-free serum (LYT2) in nonpregnant women with mild-to-severe melasma that was self-perceived as being induced by a previous pregnancy.
Methods: This was a 12-week, single-center, clinical usage study with visits at baseline and Weeks 4, 8 and 12. Thirty female subjects aged 30 to 50 years with Fitzpatrick Skin Types (FST) II to IV presenting with mild-to-severe overall hyperpigmentation on the face due to melasma, which was self-perceived to be induced by a previous pregnancy, completed the study. Seventy-three percent of the subjects were Caucasian, 20 percent were Asian, and seven percent were African American. All subjects received LYT2, cleanser, moisturizer, and sunscreen. Subjects applied LYT2 twice-daily after cleansing. All subjects used cleanser and moisturizer twice-daily and a physical sunscreen once in the morning (and as needed throughout the day). At all visits, the investigator assessed for overall hyperpigmentation (0–9 scale; 0=none, 1–3=mild, 4–6=moderate, 7–9=severe), global Improvement in Overall Hyperpigmentation (0–5 scale), and Melasma Area and Severity Index (MASI). Each subject’s face was divided into four areas that were evaluated separately (forehead [F], right malar region [MR], left malar region [ML], and chin [C]). For each area, the pigment intensity (PI), lesion size (A), and homogeneity (H) were assessed. MASI score for the whole face was calculated using the following equation: MASI=0.3 (PIF + HF) AF + 0.3 (PIMR + HMR) AMR + 0.3 (PIML+ HML) AML + 0.1 (PIC + HC) AC. The values 0.3, 0.3, 0.3, and 0.1 represent the respective percentages of total facial area. The maximum score for MASI is 48 and the minimum score is 0. Tolerability assessments for erythema, scaling, edema, burning, stinging, and itching were graded on a 4-point scale at all visits. At all follow-up visits, subjects completed a self-assessment questionnaire on self- perceived efficacy, product texture, and product attributes. At baseline and Week 12, subjects completed a Melasma Quality of Life (MelasQol) Questionnaire (Likert Scale: 1=not bothered at all to 7=bothered all the time).Standardized digital photographs were taken using the VISIA-CR Imaging System (Canfield Imaging Systems) at all visits. Image analysis on a target dark spot for skin brightness (L*) was conducted for each time point. Corneometer and tewameter measurements were conducted for all visits.
Results: The HQ-free and retinol-free serum demonstrated a statistically significant decrease in clinical grading scores at Weeks 4, 8, and 12 when compared with baseline for overall hyperpigmentation, global improvement in overall hyperpigmentation, and MASI (all p<0.001; Wilcoxon Signed-Rank Test). Statistically significant increase in mean scores for global improvement in overall hyperpigmentation at all visits (all p<0.001; Wilcoxon Signed-Rank Test). MelasQol Combined Score showed a statistically significant improvement at Week 12 compared to baseline, indicating an increased perception of quality of life (p<0.03; Wilcoxon signed-rank test). Corneometer and tewameter measurements continuously improved from baseline at all follow-up visits, indicating an improvement in skin hydration and skin barrier function, respectively. Image analysis for brightness (L*) showed statistically significant improvements from baseline at all follow up visits (all p?0.025; paired t-test). LYT2 was well tolerated with tolerability scores remaining similar to baseline scores, and highly rated by subjects for self-perceived efficacy and product attributes with a significant proportion of subjects agreeing to favorable responses by Week 12. Ninety-seven percent of subjects were satisfied with LYT2 by Week 12. Seventy-seven percent of subjects saw moderate or marked improvement by Week 12. Eighty-three percent of subjects agreed it performed better than past facial treatments.
Conclusion: Results from this study support the efficacy and tolerability of this HQ-free and retinol-free serum in improving the appearance of mild-to-severe facial melasma in subjects with self-perceived pregnancy-induced melasma.
Funding/Disclosures: This study was sponsored by Allergan. All authors met the ICMJE authorship criteria. All authors are employees of Allergan.