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ACTIVE NOT RECRUITING
NCT07034560
PHASE4

Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma

Sponsor: Thammasat University

View on ClinicalTrials.gov

Summary

This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches. Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream. After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma. The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction. This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.

Official title: Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-11-12

Completion Date

2025-11-06

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

DRUG

Tranexamic Acid (TXA)

500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks.

DRUG

melatonin (Circadin)

2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks.

DRUG

Placebo

Placebo capsule identical in appearance, taken once daily at bedtime for 12 weeks.

Locations (1)

Benchakitti Park Hospital

Bangkok, Bangkok, Thailand