Efficacy and Tolerability of 0.2% Thiamidol Cream for Facial Hyperpigmentation: A Randomized, Double-Blind, and...

Facial hyperpigmentation is a condition that often shows limited response to treatment. Thiamidol is a proven human tyrosinase (hTyr) inhibitor. However, evidence from randomized controlled trials evaluating the effectiveness of Thiamidol in reducing facial hyperpigmentation remains limited.

This study is the first and largest randomized, double-blind, vehicle-controlled trial to evaluate the effectiveness of 0.2% Thiamidol cream in the treatment of facial hyperpigmentation in both sexes. A total of 200 participants with facial hyperpigmentation were randomized to either a Thiamidol cream or a vehicle cream group for 12 weeks. Blinded physicians assessed participants' scores on the modified Melasma Area and Severity Index (mMASI) using standardized photographs, with physician and patient global assessments and digital color analysis performed at weeks 4, 8, and 12.

Of the 200 participants enrolled, 196 completed the study. The Thiamidol group showed significantly greater reductions in their mMASI scores (indicating improvement) than the vehicle group at all time points: the reduction from baseline were 11.8% vs 5.4% at week 4, 27.9% vs 13.6% at week 8, and 36.1% vs 16.1% at week 12 (all P < 0.001). The physician global assessments indicated slight to moderate improvement at weeks 8 and 12 (P < 0.001 and P = 0.001, respectively). The patient global assessments and digital color analysis showed no significant differences between groups. We found no statistically significant differences between the groups in the improvement of freckles or solar lentigines. No significant adverse events were reported in either group.

We found Thiamidol to be effective, well tolerated, and suitable for both sexes in the treatment of facial hyperpigmentation. These findings support its potential for broader clinical application in cosmetic dermatology.

ClinicalTrials.gov (NCT03926845).