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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Group A will receive oral melatonin 5mg every night for 3 months
Group B will receive oral tranexamic acid 250mg twice daily for 3 months.
PAEC General Hospital Islamabad Pakistan
Islamabad, Punjab Province, Pakistan
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.
Time frame: 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.
Time frame: 12 weeks
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