Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

NCT07169383 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: PAECGHIslamabad
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties. The findings will assess whether melatonin provides better efficacy and tolerance compared to tranexamic acid in managing this persistent condition. Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs: \<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response \>75% improvement Excellent Response

Conditions

Melasma (Facial Melasma)

Keywords

Management of Melasma

Outcome Measures

Primary Outcomes (2)

• Total participants are 160, 80 in Group A and 80 in Group B

  Group A will receive oral melatonin 5mg HS for 12 weeks and Group B will receive oral tranexamic acid 250 mg BD for 12 weeks and then the improvement will be assessed by calculating MASI score at day 1, 6weeks and 12 weeks.MASI score less than 10 is considered mild , 11-20 is considered moderate and more than 20 is considered Severe Melasma. An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.

  12 weeks

• Efficacy of Oral Melatonin VS Oral Tranexamic Acid in the management of Melasma

  As per literature Melatonin may be more effective due to its Antioxidant, Anti-inflammatory and anti-melanogenic properties. The findings will assess whether Melatonin provides better efficacy and tolerance compared to Tranexamic Acid in managing Melasma.An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.

  12 weeks

Study Arms (2)

Group A - Oral melatonin

ACTIVE COMPARATOR

Group A will receive oral melatonin 5mg daily at night for 3 months after ruling out any contraindications. Melasma Area and severity index will be calculated at day one , 6 weeks and 12 weeks.

Drug: Melatonin tablet

Group B - Oral tranexamic acid

ACTIVE COMPARATOR

Group B will receive oral tranexamic acid 250mg twice daily for 3 months after ruling out any contraindications.Melasma area and severity index will than be calculated on day one , 6 weeks and 12 weeks.

Drug: Tranexamic Acid (TXA)

Interventions

Melatonin tablet DRUG

Group A will receive oral melatonin 5mg every night for 3 months

Group A - Oral melatonin

Tranexamic Acid (TXA) DRUG

Group B will receive oral tranexamic acid 250mg twice daily for 3 months.

Group B - Oral tranexamic acid

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-50 years diagnosed with melasma.
• Both genders.

You may not qualify if:

• Patients with contraindications to melatonin, including pregnancy, breastfeeding, autoimmune disorders, bleeding disorders, and diabetes, or contraindications to tranexamic acid, including thromboembolic events, history of thrombosis, renal impairment, and pregnancy or breastfeeding.
• Patients with a history of hypersensitivity to any of the medications.
• Patients already taking treatment of melasma

Sponsors & Collaborators

• Hina Malik: lead

Study Sites (1)

PAEC General Hospital Islamabad Pakistan

Islamabad, Punjab Province, 44000, Pakistan

Location

Related Links

• Oral Melatonin 5mg is proved to be beneficial in the management of melasma
• Oral Tranexamic Acid 250 mg twice a day is proved to be benefiical in the management of melasma.

MeSH Terms

Conditions

Melanosis

Interventions

Melatonin; Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Trainee

Model Details: Efficacy of oral melatonin and oral tranexamic acid in the management of melasma is given in patients to assess the effect of both the drugs. Two groups containing 80 participants in each. Group A is assigned oral melatonin 5mg every night for 3 months while Group B is assigned oral tranexamic acid 250mg twice daily for 3 months and then MASI score is calculated at Day One , 6 weeks and at 12 weeks.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 11, 2025
• Study Start: June 28, 2025
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2026 to janurary 2027
• Access Criteria: De-identified IPD will be shared with qualified researchers who submit a proposal for secondary analysis that aligns with the trial's objectives and methodology. Proposals must outline planned analyses, including statistical methods, and will be reviewed by an independent committee for scientific merit and feasibility. A data sharing agreement must be signed, ensuring participant confidentiality and data protection. Requests can be sent to dr.hina567@gmail.com. Access will be granted for analyses that advance knowledge in melasma management, such as exploring treatment efficacy, safety, or predictors of response.

Locations

PA (1)