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

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.

Timeline

Start

2026-07-01

Primary completion

2026-12-01

Completion

2027-06-01

Publications

• Background Hussain A, Shahbaz U, Shaheen E, Ghias A, Raffad K, Khalid A, Aman S. Comparison of effectiveness and safety of topical 30% metformin versus 4% hydroquinone in the treatment of epidermal melasma. J Pak Assoc Dermatol. 2024;34(1):73-9.
• Background AboAlsoud ES, Eldahshan RM, AbouKhodair Mohammed H, Elsaie ML. Safety and efficacy of topical metformin 30% cream versus triple combination cream (Kligman's formula) in treating melasma: A randomized controlled study. J Cosmet Dermatol. 2022 Jun;21(6):2508-2515. doi: 10.1111/jocd.14953. Epub 2022 Apr 9.
• Background Belisle ES, Park HY. Metformin: a potential drug to treat hyperpigmentation disorders. J Invest Dermatol. 2014 Oct;134(10):2488-2491. doi: 10.1038/jid.2014.245.
• Background Mongkhon P, Ruengorn C, Awiphan R, Phosuya C, Ruanta Y, Thavorn K, Jamjanya S, Chuamanochan M, Nochaiwong S. Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis. Front Pharmacol. 2023 Dec 13;14:1281050. doi: 10.3389/fphar.2023.1281050. eCollection 2023.
• Background Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
• Background Mapar M, Hemmati AA, Namdari G. Comparing the efficacy of topical metformin and placebo in the treatment of melasma: a randomized, double-blind, clinical trial. J Pharm Res Int. 2019;30(4):1-8. doi:10.9734/jpri/2019/v30i430276.

Drugs

Indications