COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS

Melasma is a chronic hyperpigmentation disorder of multifactorial origin, often aggravated by ultraviolet (UV) radiation, hormonal changes, and inflammation. It predominantly affects individuals with Fitzpatrick skin phototypes III to V and manifests as irregular brown macules and patches, particularly on sun-exposed facial areas. While 4% hydroquinone remains the gold standard topical agent for melasma, its long-term use is associated with adverse events such as irritant dermatitis and exogenous ochronosis, prompting the development of alternative dermocosmetic formulations. This double-blind, randomized, controlled trial investigates the comparative efficacy and cutaneous tolerance of an intensive anti-spot cosmetic serum (Depiwhite Serum) versus a hydroquinone 4% cream (Eldopinone), both used in conjunction with a high-protection SPF50+ sunscreen (Depiwhite.M). The serum incorporates a combination of active ingredients designed to target melanogenesis and its upstream mediators through a multi-pathway mechanism, including anti-inflammatory, antioxidant, and melanin-regulatory actions. The study will evaluate changes in melasma severity using a modified Melasma Area and Severity Index (mMASI) score and standardized facial photography acquired with the ColorFace® imaging system. These photographs will undergo high-resolution colorimetric analysis by QIMA Life Sciences, quantifying pigmentation changes through CIELab parameters (L\*, a\*, b\*), ITA°, and contrast metrics (ΔE76, ΔITA°, etc.), tracked across predefined regions of interest (ROIs) from lesional and perilesional skin. Additional assessments include subjective product performance evaluation, cosmetic acceptability, and patient-reported outcomes using two validated quality-of-life instruments (MELASQoL and ASLQI). Safety and local tolerance will be monitored at each clinical visit via dermatologist-led skin examinations and subject-reported functional symptoms. The trial aims to generate robust clinical and instrumental data supporting the use of cosmetic formulations as a potential alternative or maintenance therapy to hydroquinone in melasma management, particularly for populations seeking better tolerability profiles without compromising efficacy. Amendment Note (15 August 2025 The inclusion criteria have been revised to allow subjects with a baseline mMASI score of ≥3.5 (previously ≥4) to accommodate borderline moderate melasma cases. This change is reflected in Protocol Version 2.0.