Clinical Trial

Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma

Study acronym: TXA-MELA
Active, Not Recruiting Phase 4
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Record status
This record was last updated June 24, 2025 (before its estimated November 6, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches. Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream. After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma. The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction. This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.
Trial Details
NCT Number NCT07034560
Lead Sponsor Thammasat University
Conditions Melasma, Treatment Outcome, Recurrence
Enrollment 75 participants
Start Date 2024-11-12
Primary Completion 2025-11-06 (estimated)
Study Completion 2025-11-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-24