About this trial
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.
Eligibility criteria
Qualifiers
Female patients aged 35-55 years
Clinically diagnosed epidermal or dermal melasma (confirmed by Wood's lamp examination)
Fitzpatrick skin types III-V
Duration of melasma ≥6 months
Disqualifiers
Pregnancy or lactation
Known allergy to study medications
Active facial dermatitis, acne, or recent cosmetic procedures
Trial design
Treatments tested in this trial
- Topical 30% metformin cream
- Kligman's Regimen
Treatment groups
Sponsors and collaborators
Foundation University Islamabad
Lead sponsor
Fauji Foundation Hospital
Collaborator