Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
Trial Snapshot
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Total participants are 160, 80 in Group A and 80 in Group B
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Tranexamic Acid (TXA) (Drug)
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.
Intervention: Melatonin tablet (Drug)
Outcomes
Primary Outcomes
Total participants are 160, 80 in Group A and 80 in Group B
Time Frame: 12 weeks
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.
Efficacy of Oral Melatonin VS Oral Tranexamic Acid in the management of Melasma
Time Frame: 12 weeks
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hina Malik
Post Graduate Trainee
PAEC General Hospital, Islamabad