Clinical Trial

Comparative Evaluation of Topical 30% Metformin and Kligman's Regimen in Women With Melasma

Study acronym: Melasma
Not Yet Recruiting
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Summary
It's a prospective, randomised, assessor-blinded clinical study comparing topical 30% metformin with Kligman's regimen for melasma in women aged 35-55 years at Fauji Foundation Hospital, Rawalpindi. The study seeks to ascertain which treatment yields a more significant decrease in the modified MASI score over an 8-week period and which treatment is associated with fewer adverse effects, such as erythema, burning, peeling, and post-inflammatory hyperpigmentation. A total of 82 participants will be enrolled and randomly assigned to either metformin cream or Kligman's regimen, with both groups also using sunscreen. Assessments will be done at baseline, week 4, and week 8 through mMASI scoring, photographs, and side-effect monitoring. Data will be analyzed in SPSS 26 using t-tests and chi-square testing. The study is based on evidence suggesting metformin may offer comparable efficacy with better tolerability.
Trial Details
NCT Number NCT07485777
Lead Sponsor Foundation University Islamabad
Collaborators: Fauji Foundation Hospital
Conditions Melasma (Facial Melasma), Melasma
Enrollment 82 participants
Start Date 2026-07-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-20