Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma

Hina Malik

Status and phase: Invitation-only; Phase 2

Conditions: Melasma (Facial Melasma)

Treatments: Drug: Tranexamic Acid (TXA); Drug: Melatonin tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07169383

PAECGHIslamabad

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group A - Oral melatonin

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin tablet

Group B - Oral tranexamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid (TXA)