BACKGROUND: Skin hyperpigmentation is a dermatological concern for pigmented skin phototypes. Despite availability of multiple treatment options, hyperpigmentation management continues to be a challenge. AIMS: Efficacy and safety assessment of the skincare regimen [topical formulation of trihydroxybenzoic acid glucoside 10% (THBG) and α-arbutin 2% (twice-daily) + sunscreen (once daily)] in Indian females with pigmentary spots (facial dark spots or melasma). METHODS: This prospective, open-label, single-arm, interventional study was conducted in Indian females (n = 124), aged 18-45 years, having FitzPatrick skin type III-IV, dull skin, and facial dark spots or melasma. Efficacy of 90-day skincare regimen was evaluated using mexameter, modified melasma area and severity index (mMASI) score, cross-polarized light photography, chromameter, and color-luminosity-brightness-transparency (CLBT) technique. Student's t-test (paired data) was used for statistical analysis. RESULTS: In efficacy analysis [modified intention-to-treat (mITT) population], 120 subjects were included. Melanin content of pigmentary spots (on mexametry) significantly reduced (-16.3%, p <
0.001) at Day 90 versus baseline. Significant reduction in severity of melasma was observed (-18.4% in mMASI score) at Day 90. Significant improvement in ΔEab (-8.7%) (change in color difference between pigmentary spot and normal skin) on cross-polarized photographs, in skin-brightening parameters L* (relative brightness/lightness) (-2.7%), ITA° (individual typology angle) (-37.7%), and ΔE* (skin-tone evenness) (-19.0%) using chromameter. Significant improvement in skin radiance was observed in CLBT parameters, color (pink: 32.8%, yellow: -5.5%, and olive: -7.8%), luminosity (6.0%), brightness (4.6%), and transparency (0.2%). Regimen did not cause itching, burning, or irritation. CONCLUSIONS: Skincare regime of 10% THBG and 2% α-arbutin along with sunscreen was effective in reducing pigmentary spots (dark spots and melasma) and was well tolerated in Indian women. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI Reg. No. CTRI/2021/11/038345
date: 30/11/2021).