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

Phase 4Active Not RecruitingNCT07034560

Thammasat University75 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 12, Week 16, Week 20, Week 24

Secondary Outcomes

Melanin and Erythema Index

Change in Melanin Index and Erythema Index at baseline to 24 weeks, measured by Mexameter. Higher values indicate increased pigmentation and erythema, respectively

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

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

Quantitative skin analysis using Antera 3D® imaging at baseline to 24 weeks. Lower scores indicate smoother texture, smaller pores, and fewer fine lines.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Dermatology Life Quality Index (DLQI) score

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.

Time frame: Baseline, Week 12, Week 24

Patient satisfaction (Visual Analog Scale)

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

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Adverse events (AEs)

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

Time frame: Week 4, Week 8, Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes