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ENROLLING BY INVITATION
NCT07169383
PHASE2

Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

Sponsor: Hina Malik

View on ClinicalTrials.gov

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

Official title: Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-06-28

Completion Date

2025-12-28

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DRUG

Melatonin tablet

Group A will receive oral melatonin 5mg every night for 3 months

DRUG

Tranexamic Acid (TXA)

Group B will receive oral tranexamic acid 250mg twice daily for 3 months.

Locations (1)

PAEC General Hospital Islamabad Pakistan

Islamabad, Punjab Province, Pakistan