Thiamidol® in moderate-to-severe melasma: 24-week, randomized, double-blind, vehicle-controlled clinical study with subsequent regression phase.

ABSTRACT

Thiamidol® was the most potent inhibitor of human tyrosinase out of 50 000 screened substances. In vivo, it was well tolerated and improved melasma significantly. This was the first 24-week, randomized, double-blind, vehicle-controlled, cosmetic clinical study to assess the efficacy and tolerability of thiamidol in moderate-to-severe melasma of phototype III-V subjects with subsequent regression phase. Females allocated to verum (n = 23), applied daily Dual Serum followed either by Day Care SPF30 in the morning or by Night Care in the evening, all containing Thiamidol. The vehicle group (25 females) followed the same skin care routine using the corresponding vehicle formulations. Subjects came back for a follow-up visit 13-20 weeks after treatment (regression phase). Assessments included clinical photography, Melasma Area and Severity Index (MASI), skin lightness, quality of life, and tolerability. Baseline demographics and hyperpigmentation were well balanced across the treatment groups. Clinical photography and MASI improved with Thiamidol significantly versus baseline (p < 0.001) and vehicle (p < 0.001-0.043) at all time points up to treatment end. At follow-up, the MASI was still significantly lower than at baseline but similar for verum and vehicle. Skin lightness and quality of life improved significantly versus baseline without significant differences between verum and vehicle. This study demonstrated that Thiamidol is well tolerated and superior in improving melasma compared to baseline and vehicle over a treatment period of 24 weeks.