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NCT Number: NCT07034560

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Melasma Disease Attributes Hyperpigmentation Melanosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Recurrence Skin Diseases Skin and Connective Tissue Diseases Treatment Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benchakitti Park Hospital

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Patients with Hori's nevus

Treatment and study plan

Tranexamic acid (TXA)

Drug

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

melatonin (Circadin)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Adverse events (AEs)

    Time frame: Week 4, Week 8, Week 12

    Number and severity of treatment-emergent adverse events during the 12-week intervention

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Acronym: TXA-MELA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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