Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

NCT ID: NCT07169383

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-28
• Study Completion Date: 2025-12-28

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

Detailed Description

This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma.Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties.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 It's a Randomized Control Trial conducted at PAEC General Hospital. Study period is of 6 months.Total sample size is 180 patents.The sample is divided into two groups, with 80 patients assigned to each treatment.This study hypothesizes that oral melatonin will be more effective than oral tranexamic acid in reducing the severity of melasma, as measured by changes in the Melasma Area and Severity Index.

Conditions

Melasma (Facial Melasma)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A - Oral melatonin

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.

Group Type: ACTIVE_COMPARATOR

Melatonin tablet

Intervention Type: DRUG

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

Group B - Oral tranexamic acid

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type: DRUG

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

Interventions

Melatonin tablet

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

Intervention Type: DRUG

Tranexamic Acid (TXA)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hina Malik

OTHER

Sponsor Role: lead

Responsible Party

Hina Malik

Post Graduate Trainee

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

PAEC General Hospital Islamabad Pakistan

Islamabad, Punjab Province, Pakistan

Countries

Pakistan

Related Links

https://pubmed.ncbi.nlm.nih.gov/38226560/

Oral Melatonin 5mg is proved to be beneficial in the management of melasma

https://pubmed.ncbi.nlm.nih.gov/30536592/

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

Other Identifiers

PAECGHIslamabad

Identifier Type: -

Identifier Source: org_study_id