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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-55
SponsorFoundation University Islamabad

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

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Foundation University Islamabad

Lead sponsor

Fauji Foundation Hospital

Collaborator