Safety and efficacy of topical metformin 30% cream versus triple combination cream (Kligman's formula) in treating melasma: A randomized controlled study

Oct 10, 2026

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Melasma is a common acquired facial pigmentary disorder presenting as hyperpigmented macules, with triple combination creams (TCC, Kligman’s formula) used as a long-standing standard despite side effects. A randomized controlled trial enrolled 40 adults with melasma and compared 30% topical metformin cream versus TCC over eight weeks. Melasma severity was quantified using MASI at baseline and week 8. MASI decreased significantly in both groups, with no statistically significant between-group difference. Metformin cream showed a favorable safety profile.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Abstract

Background

Aim of the work

Patients and Methods

Results

Conclusion

Introduction

Materials and Methods

Received: 8 November 2021 Revised: 3 March 2022 Accepted: 28 March 2022 DOI: 10. 1111/jocd.14953 OR I G I NAL ART I C L E Safety and efficacy of topical metformin 30% cream versus triple combination cream (Kligman's formula) in treating melasma: A randomized controlled study Eman Said AboAlsoud MD1 | Ramadan Mohamed Eldahshan MD1 | Hassan AbouKhodair Mohammed MD1 | Mohamed L. Elsaie MD2 1Department of Dermatology, Venereology and Andrology Damietta Faculty of Medicine, Al-Azhar University, New Damietta, Egypt 2Department of Dermatology, National Research Centre, Cairo, Egypt Correspondence Mohamed L. Elsaie, Department of Dermatology, National Research Centre, Cairo, Egypt. Email: [egydoc77@yahoo.com](egydoc77@yahoo.com) Abstract Background: Melasma is an acquired common pigmentary condition that mostly presents as pigmented macules on the face. Triple combination creams (TCC), commonly known as kligman's formula, had been regarded as the mainstay of treatment for years. Topical metformin was recently studied for its melanopenic effects and potential use in melasma. Aim of the work: This study aimed to evaluate the efficacy and safety of using 30% metformin cream to that of triple combination creams (Kligman's formula) in treating melasma. Patients and Methods: About 40 patients complaining of melasma were recruited for this controlled randomized trial and were divided into 2 groups. Group 1 (n = 20) subjects received 30% metformin cream whereas group 2 (n = 20) were treated with TCC for eight consecutive weeks. Pigmentation severity and improvements were assessed using the melasma area severity index (MASI) at baseline and after 8 weeks of using treatment. Results: MASI score decreased dramatically from 12.18 ± 9.33 before treatment to 5.59 ± 4.61 at Week 8 with a mean decrease percentage of 55.97 ± 16.77 for group 1 (p = 0.001) and from 16.05 ± 8.73 to 7.54 ± 5.77 with a mean decrease percentage of 56.50 ± 19.44 for group 2 (p = 0.001) . No significant difference was reported between the two treatment modalities regarding the reduction in melasma throughout the study period (p = 0.968) . Conclusion: Metformin cream is a safe, potential effective treatment for melasma, which needs to be verified by long-term large scale studies in diffident populations. K E Y WO R D S dermoscopy, melasma, metformin, triple combination creams 1 | INTRODUCTION Melasma, also known as chloasma or mask of pregnancy, is a recurrent, acquired, hyperpigmentary disorder usually affecting females.1 Despite of prevalence rates varying between 3% and 33% among different populations, the exact mechanism for pathogenesis of melasma remains to be fully elucidated.2 The pathogenesis of melasma remains largely unknown with ultraviolet exposure being a major triggering factor. Other common contributing factors include genetic predisposition, pregnancy, oral contraceptives, endocrine dysfunction, hormonal treatments, drugs containing phototoxic agents, and stress.3 2508 | © 2022 Wiley Periodicals LLC [wileyonlinelibrary.com/journal/jocd](wileyonlinelibrary.com/journal/jocd) J Cosmet Dermatol. 2022;21:2508–2515 . Management of melasma is challenging owing to its recurrent nature and requirement for longer duration of treatment. No single approach exists to combat melasma; however, triple combination creams (TCC) remains to be the golden standard of treatment, however, with associated side effects on long-term application.4 Metformin, though primarily an antidiabetic drug, has found to play an important role in a number of cutaneous disorders. Because of its role in improving hyperinsulinemia, it has proven beneficial in hormonal acne, hidradenitis suppurativa (HS), and acanthosis nigricans.5 Recently, metformin has also been shown to express a downregulating effect on melanogeneiss and could be of potential use in hyperpigmentary disorders.6 Hence, this study was undertaken to evaluate the safety and efficacy

FAQs

How many participants were included, and how were they assigned to treatments?

The trial recruited about 40 patients with melasma and randomly divided them into two groups of 20 each. Group 1 received 30% metformin cream and Group 2 received TCC for eight consecutive weeks.

What outcome measure was used to assess melasma severity?

Melasma severity was assessed using the Melasma Area and Severity Index (MASI) at baseline and after 8 weeks of treatment.

Did metformin cream perform better than triple combination cream in reducing MASI?

Both treatments significantly reduced MASI scores. However, no significant difference was reported between the two treatment modalities regarding reduction in melasma over the study period (p = 0.968).

What safety conclusion was drawn from the study?

The study concluded that metformin cream is a safe and potentially effective treatment for melasma, while recommending confirmation by long-term, large-scale studies in different populations.

Oct 10, 2026

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