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

NCT07034560 | Active Not Recruiting Phase 4

• 2 other identifiers: CICM-MELASMA-MELATONIN-2025MTU-EC-OO-0-238/67
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Melasma; Hyperpigmentation; Tranexamic Acid; Melatonin; mMASI; Recurrence; Randomized Controlled Trial; Skin Pigmentation

Outcome Measures

Primary Outcomes (2)

• Change in modified Melasma Area and Severity Index (mMASI)

  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)

  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 Outcomes (5)

• Melanin and Erythema Index

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Change in skin texture, pore size, fine line (Antera 3D imaging)

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Dermatology Life Quality Index (DLQI) score

  Baseline, Week 12, Week 24

• Patient satisfaction (Visual Analog Scale)

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Adverse events (AEs)

  Week 4, Week 8, Week 12

Study Arms (3)

Tranexamic Acid (TXA)

ACTIVE COMPARATOR

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)

melatonin (Circadin)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid (TXA) DRUG

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

Tranexamic Acid (TXA)

melatonin (Circadin) DRUG

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

melatonin (Circadin)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the age above 18 years and above
• Patients diagnosed with epidermal or mixed-type melasma

You may not qualify if:

• 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
• Chemical peeling within 4 weeks prior to joining the study
• Use of oral tranexamic acid or any supplements within 3 months prior to joining the study
• History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study
• History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study
• Pregnancy or breastfeeding
• Use of hormonal contraceptives within 1 year prior to joining the study
• Personal or family history of thrombotic disorders, such as deep vein thrombosis, pulmonary embolism, stroke, protein C or S deficiency, or antithrombin III deficiency
• History of more than 2 spontaneous abortion
• History of impaired kidney function
• History of cancer
• Smoking
• Heart disease (e.g., end-stage heart failure, chronic obstructive pulmonary disease, or use of prosthetic heart valves)
• History of allergy to oral tranexamic acid or melatonin
• Patients who are unable to follow up as per the study protocol

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Benchakitti Park Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Melanosis; Recurrence; Hyperpigmentation; Pigmentation Disorders

Interventions

Tranexamic Acid; Melatonin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Assoc. Prof. Premjit Juntongjin, MD

  Chulabhorn International College of Medicine, Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 24, 2025
• Study Start: November 12, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)