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Comparative Evaluation of Topical 30% Metformin and Kligman's Regimen in Women With Melasma
Sponsor: Foundation University Islamabad
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.
Official title: A Novel Approach to Melasma Management: Comparative Evaluation of Topical 30% Metformin and Kligman's Regimen in Middle-Aged Women
Key Details
Gender
FEMALE
Age Range
35 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2026-07-01
Completion Date
2027-06-01
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Topical 30% metformin cream
Participants will be randomized to one of two topical drug regimens applied once nightly for 8 weeks. Both groups will also use mineral sunscreen available from the hospital pharmacy.
Kligman's Regimen
Nightly Kligman's regimen for 8 weeks with mineral sunscreen.
Locations (1)
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, Punjab Province, Pakistan