Clinical Trial

Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

Study acronym: Melasma
Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated September 11, 2025 (before its estimated December 28, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties. The findings will assess whether melatonin provides better efficacy and tolerance compared to tranexamic acid in managing this persistent condition. Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs: \<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response \>75% improvement Excellent Response
Trial Details
NCT Number NCT07169383
Lead Sponsor Hina Malik
Conditions Melasma (Facial Melasma)
Enrollment 160 participants
Start Date 2025-06-28
Primary Completion 2025-12-28 (estimated)
Study Completion 2025-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-09-11