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Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

NCT07169383 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-09-11

No results posted yet for this study

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

Conditions

  • Melasma (Facial Melasma)

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.

Sponsors & Collaborators

  • Hina Malik

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-28
Primary Completion
2025-12-28
Completion
2025-12-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07169383 on ClinicalTrials.gov