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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Topical 30% metformin cream
DrugParticipants 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
DrugNightly Kligman's regimen for 8 weeks with mineral sunscreen.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Kligman's regimenActive comparator 1 intervention
Group B: Topical 30% MetforminExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean reduction in modified MASI (mMASI) score
Compare mean reduction in mMASI score from baseline to week 8 between topical 30% metformin and Kligman's regimen.
Time frame
Baseline to 8 weeksSecondary outcomes
1
Patients with adverse effects
Proportion of participants developing adverse effects (erythema, burning, peeling/dryness, or dyspigmentation) during treatment, compared between groups at follow-up visits.
Time frame
Baseline to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Foundation University Islamabad
Lead sponsor
Fauji Foundation Hospital
Collaborator
Source ClinicalTrials.gov
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