Thiamidol containing treatment regimens in facial hyperpigmentation: An international multi‐centre approach consisting of a double‐blind, controlled, split‐face study and of an open‐label, real‐world study

OBJECTIVE: Tyrosinase is the rate‐limiting enzyme in melanogenesis. Thiamidol is the most potent inhibitor of human tyrosinase out of 50 000 tested compounds. In clinical studies, it was shown to improve facial hyperpigmentation, post‐inflammatory hyperpigmentation and age spots significantly. To identify the optimal number of daily Thiamidol applications, we conducted a split‐face study comparing the efficacy and tolerability of four‐times with two‐times daily application. Subsequently, we evaluated the efficacy and tolerability of a typical face care regimen containing Thiamidol in a real‐world study. METHODS: The split‐face study was double‐blind, randomized, controlled, including two Thiamidol containing products (serum and day care SPF 30). The serum was applied twice daily on one half of the face and the day care SPF30 twice‐daily on the whole face. The real‐world study was open‐label, observational, including three Thiamidol containing products (day care SPF 30 in the morning, serum and night care in the evening). In both studies, subjects with mild‐to‐moderate facial hyperpigmentation applied the products over 12 weeks. Assessments included clinical and subjective grading of hyperpigmentation, skin condition, hemi‐/modified MASI, chromameter and clinical photography. RESULTS: In the split‐face study (n = 34), hyperpigmentation, skin roughness and hMASI improved all significantly (P < 0.001) versus baseline, with first visible results after two weeks of twice‐daily application. The four‐times daily application led to significant improvement versus the two‐times daily application. In the real‐world study (n = 83), all evaluated parameters, including skin condition and chromametry (n = 30), improved significantly (P < 0.001) in comparison with baseline and the corresponding preceding visits. The subjects judged the cosmetic properties of the products positively. In both studies, the products were well tolerated. CONCLUSION: Four‐times daily Thiamidol improves facial hyperpigmentation significantly more than two‐times daily and is well tolerated by the subjects. The real‐world study with a typical face care regimen containing Thiamidol shows improvement of facial hyperpigmentation and confirms tolerability. Furthermore, the data provide evidence for the suitability of this three‐product Thiamidol regimen for day‐to‐day life.