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.

• 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

The plan to share de-identified individual participant data (IPD) from this clinical trial, including the efficacy of oral melatonin versus oral tranexamic acid in managing melasma, with researchers who submit a methodologically sound proposal for secondary analysis. The data shared will include the primary and secondary outcome measures, participant demographics, and other relevant study data. Data will be accessible 12 months after the primary publication of the trial results, via a secure online platform, with a data use agreement. Access will be granted to researchers who provide a detailed proposal and agree to the terms of data sharing, including maintaining participant confidentiality and not attempting to re-identify participants. Requests for data access should be directed to dr.hina567@gmail.com

This IPD sharing plan aligns with the ICMJE's expectations for data sharing and transparency in clinical trials.

January 2026 to janurary 2027

De-identified IPD will be shared with qualified researchers who submit a proposal for secondary analysis that aligns with the trial's objectives and methodology. Proposals must outline planned analyses, including statistical methods, and will be reviewed by an independent committee for scientific merit and feasibility. A data sharing agreement must be signed, ensuring participant confidentiality and data protection. Requests can be sent to dr.hina567@gmail.com. Access will be granted for analyses that advance knowledge in melasma management, such as exploring treatment efficacy, safety, or predictors of response.