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

NCT07485777 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Melasma (Facial Melasma)
  • Melasma

Interventions

DRUG

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.

DRUG

Kligman's Regimen

Nightly Kligman's regimen for 8 weeks with mineral sunscreen.

Sponsors & Collaborators

  • Fauji Foundation Hospital

    collaborator OTHER

  • Foundation University Islamabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-01
Completion
2027-06-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485777 on ClinicalTrials.gov