Clinical Research Directory

Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma

Sponsor: University of Guadalajara

Summary

The goal of this clinical trial is to learn whether a topical formulation containing 12% azelaic acid and 5% tranexamic acid is effective and safe for treating melasma in adults. The main questions it aims to answer are: Does the topical formulation reduce melasma severity compared with placebo after 4 weeks of treatment? Is the topical formulation safe and well tolerated? Researchers will compare the active topical formulation with a placebo cream to determine whether the active treatment provides greater improvement in melasma severity and quality of life. Participants will: Be randomly assigned to receive either the active topical formulation or a placebo cream. Apply the assigned treatment daily for 4 weeks. Attend scheduled clinical visits for assessment of melasma severity using the Melasma Area and Severity Index (MASI), quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system. Be monitored for local adverse events throughout the study.

Official title: Efficacy and Safety of a Combined Topical Formula (Azelaic Acid and Tranexamic Acid) Versus Placebo in Patients With Melasma: Randomized, Double-blind, Controlled Clinical Trial.

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