NCT07169383

Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Hina Malik · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma.Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties.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 It's a Randomized Control Trial conducted at PAEC General Hospital. Study period is of 6 months.Total sample size is 180 patents.The sample is divided into two groups, with 80 patients assigned to each treatment.This study hypothesizes that oral melatonin will be more effective than oral tranexamic acid in reducing the severity of melasma, as measured by changes in the Melasma Area and Severity Index.

Conditions

• Melasma (Facial Melasma)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-28
• Primary completion: 2025-12-28
• Completion: 2025-12-28
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: Pakistan