Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma (TXA-MELA)

June 19, 2025 updated by: Premjit Juntongjin, MD, Thammasat University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Melasma is a chronic skin disorder characterized by symmetrical, hyperpigmented patches on sun-exposed areas, especially the face. Although its exact cause is not fully understood, hormonal influences, ultraviolet (UV) exposure, and genetic predisposition are contributing factors.

Tranexamic acid (TXA), an antifibrinolytic agent, has shown promising results in treating melasma by inhibiting melanogenesis through the plasminogen-plasmin pathway. Melatonin (MLT), a hormone with antioxidant and anti-inflammatory properties, has also demonstrated potential benefits in melasma management by reducing oxidative stress and interfering with the melanin synthesis pathway.

This prospective, randomized, controlled, evaluator-blinded clinical trial aims to compare the efficacy and recurrence outcomes of oral TXA (500 mg), oral MLT (2 mg), and placebo, each administered once daily for 12 weeks. After discontinuing the oral treatment, all participants will continue using sunscreen and base cream for an additional 12 weeks to evaluate recurrence.

Outcome measures include modified Melasma Area and Severity Index (mMASI), Mexameter-based pigmentation indices, quality of life scores (DLQI), and patient satisfaction (VAS). The study is conducted at Benchakitti Park Hospital and includes 75 adult participants with epidermal or mixed-type melasma.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Benchakitti Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with the age above 18 years and above
  2. Patients diagnosed with epidermal or mixed-type melasma

Exclusion Criteria:

  1. Use of topical medications such as hydroquinone, whitening agents (e.g., arbutin, kojic acid, vitamin C, retinoids, and steroids) on melasma areas within 4 weeks prior to joining the study
  2. Chemical peeling within 4 weeks prior to joining the study
  3. Use of oral tranexamic acid or any supplements within 3 months prior to joining the study
  4. History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study
  5. History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study
  6. Pregnancy or breastfeeding
  7. Use of hormonal contraceptives within 1 year prior to joining the study
  8. Personal or family history of thrombotic disorders, such as deep vein thrombosis, pulmonary embolism, stroke, protein C or S deficiency, or antithrombin III deficiency
  9. History of more than 2 spontaneous abortion
  10. History of impaired kidney function
  11. History of cancer
  12. Smoking
  13. Heart disease (e.g., end-stage heart failure, chronic obstructive pulmonary disease, or use of prosthetic heart valves)
  14. History of allergy to oral tranexamic acid or melatonin
  15. Patients who are unable to follow up as per the study protocol
  16. Patients with Hori's nevus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tranexamic Acid (TXA)
Participants will receive 500 mg of oral tranexamic acid (Transamin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
Drug: Tranexamic Acid (TXA)
500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks.
Experimental: melatonin (Circadin)
Participants will receive 2 mg of oral melatonin (Circadin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
Drug: melatonin (Circadin)
2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks.
Placebo Comparator: Placebo
Participants will receive a placebo capsule once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
Drug: Placebo
Placebo capsule identical in appearance, taken once daily at bedtime for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modified Melasma Area and Severity Index (mMASI)
Time Frame: Baseline, Week 4, Week 8, Week 12

Change in modified Melasma Area and Severity Index (mMASI) score from baseline to Week 12.

The mMASI ranges from 0 to 14.4, with higher scores indicating more severe melasma.
Baseline, Week 4, Week 8, Week 12
Change in modified Melasma Area and Severity Index (mMASI) (Recurrence)
Time Frame: Week 12, Week 16, Week 20, Week 24

Recurrence is defined as an increase in mMASI score ≥50% from Week 12 to Week 24.

The mMASI ranges from 0 to 14.4; higher scores indicate worse melasma.
Week 12, Week 16, Week 20, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanin and Erythema Index
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Change in Melanin Index and Erythema Index at baseline to 24 weeks, measured by Mexameter.

Higher values indicate increased pigmentation and erythema, respectively
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change in skin texture, pore size, fine line (Antera 3D imaging)
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Quantitative skin analysis using Antera 3D® imaging at baseline to 24 weeks. Lower scores indicate smoother texture, smaller pores, and fewer fine lines.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Dermatology Life Quality Index (DLQI) score
Time Frame: Baseline, Week 12, Week 24
Change in Dermatology Life Quality Index (DLQI) from baseline to 24 weeks. DLQI ranges from 0 to 30. Higher scores indicate greater impairment in quality of life.
Baseline, Week 12, Week 24
Patient satisfaction (Visual Analog Scale)
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Patient satisfaction score at every 4 weeks using Visual Analog Scale (VAS) from 0 to 10.

Higher scores indicate greater satisfaction.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Adverse events (AEs)
Time Frame: Week 4, Week 8, Week 12
Number and severity of treatment-emergent adverse events during the 12-week intervention
Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Assoc. Prof. Premjit Juntongjin, MD, Chulabhorn International College of Medicine, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

November 6, 2025

Study Completion (Estimated)

November 6, 2025

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

June 19, 2025

First Posted (Actual)

June 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICM-MELASMA-MELATONIN-2025
  • MTU-EC-OO-0-238/67 (Other Identifier: Human Research Ethics Committee, Faculty of Medicine, Thammasat University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to confidentiality concerns and lack of a formal data-sharing infrastructure. Data will be available upon reasonable request in de-identified, summary form only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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