Efficacy and safety of topical trihydroxybenzoic acid glucoside and alpha-arbutin containing formulation along with a sunscreen in facial hyperpigmentation

Abstract

Background: Facial hyperpigmentation is a common presentation in Indian subjects and its treatment is complex. The aim of the study was to evaluate efficacy and safety of a 56-day skincare regimen of topical 3,4,5-trihydroxybenzoic acid glucoside (THBG/Brightenyl^®) and α-arbutin containing formulation along with a sunscreen in the management of facial dark spots and melasma. Methods: Thirty-six female subjects with facial dark spots or melasma who met inclusion/exclusion criteria were enrolled in a prospective, single-arm, study in India. Subjects applied a skin brightening cream containing 10% THBG and 2% α-arbutin twice daily in combination with a sunscreen (SPF=55) once daily; on their whole face for 56 days. Evaluation was carried out at baseline, days 28, 42 and 56 by the same dermatologist and technician. Efficacy was evaluated using mexameter, modified Melasma Area and Severity Index (mMASI), chromameter and cross-polarized light photography. Results: There was a significant reduction in melanin content (mexametry) and mMASI score compared with the baseline. On chromametry, a significant improvement was seen in skin brightness/lightness (L*) and pigmentation [individual typology angle (ITA°)] demonstrating modification in skin color with an improvement in homogeneity/evenness of the skin tone (ΔE*) from the baseline. At day 56, the total area of the pigmentary spots on the cheeks showed a significant reduction compared to baseline using cross-polarized light photography. The treatment was well tolerated. Conclusions: This study demonstrates that application of formulation containing 10% THBG and 2% α-arbutin along with a sunscreen is well-tolerated and efficacious in the management of facial hyperpigmentation like dark spots or melasma.