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

NCT07034560 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Melasma
  • Treatment Outcome
  • Recurrence

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.

Sponsors & Collaborators

  • Thammasat University

    lead OTHER

Principal Investigators

  • Assoc. Prof. Premjit Juntongjin, MD · Chulabhorn International College of Medicine, Thammasat University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2025-11-06
Completion
2025-11-06

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

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 NCT07034560 on ClinicalTrials.gov