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NCT07169383: Melasma

Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

ENROLLING BY INVITATION Phase 2 Last updated 11 September 2025
What this trial tests

Phase 2 trial testing Melatonin tablet in Melasma (Facial Melasma) in 160 participants. Enrolling by invitation.

Timeline
28 June 2025
Primary endpoint
28 December 2025
28 December 2025

Quick facts

Lead sponsorHina Malik
PhasePhase 2
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment160
Start date28 June 2025
Primary completion28 December 2025
Estimated completion28 December 2025
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

Hina Malik

Who can join

Adults 18 to 50, any sex, with Melasma (Facial Melasma). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Melasma (Facial Melasma)

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07169383.

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