Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin tablet, Tranexamic Acid (TXA).
- Who it may be relevant to
- Registry conditions: Melasma (Facial Melasma). Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
Overview
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.
Interventions
- Drug Melatonin tablet
Group A will receive oral melatonin 5mg every night for 3 months - Drug Tranexamic Acid (TXA)
Group B will receive oral tranexamic acid 250mg twice daily for 3 months.
Primary outcome measures
- Total participants are 160, 80 in Group A and 80 in Group B [Time frame: 12 weeks]
- Efficacy of Oral Melatonin VS Oral Tranexamic Acid in the management of Melasma [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- PAEC General Hospital Islamabad Pakistan — Islamabad
Identifiers
NCT: NCT07169383 · PAECGHIslamabad