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

NCT07485777 | Not Yet Recruiting

• 1 other identifier: FUMCRCT4
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Melasma; topical metformin; kligman regimen; hyper-pigmentation; mMASI

Outcome Measures

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.

  Baseline to 8 weeks

Secondary Outcomes (1)

• Patients with adverse effects

  Baseline to 8 weeks

Study Arms (2)

Kligman's regimen

ACTIVE COMPARATOR

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

Drug: Kligman's Regimen

Topical 30% Metformin

EXPERIMENTAL

Participants will apply topical 30% metformin cream once nightly on affected facial areas for 8 weeks, with concurrent use of mineral sunscreen.

Drug: Topical 30% metformin cream

Interventions

Topical 30% metformin cream DRUG

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.

Also known as: kligman regimen

Topical 30% Metformin

Kligman's Regimen DRUG

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

Kligman's regimen

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: biological female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• No topical or systemic treatment for melasma in the past month

You may not qualify if:

• Pregnancy or lactation
• Known allergy to study medications
• Active facial dermatitis, acne, or recent cosmetic procedures

Sponsors & Collaborators

• Foundation University Islamabad: lead
• Fauji Foundation Hospital: collaborator

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (6)

• 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 MH, 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;21(6):2508-15. doi:10.1111/jocd.14953.

  BACKGROUND

• Belisle ES, Park HY. Metformin: a potential drug to treat hyperpigmentation disorders. J Invest Dermatol. 2014;134(10):2488-91. doi:10.1038/jid.2014.245.

  BACKGROUND

• Mongkhon P, Ruengorn C, Awiphan R, Phosuya C, Ruanta Y, Thavorn K, et al. Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis. Front Pharmacol. 2023;14:1281050. doi:10.3389/fphar.2023.1281050.

  BACKGROUND

• Ogbechie-Godec OA, Elbuluk N. Melasma: an up-to-date comprehensive review. Dermatol Ther (Heidelb). 2017;7(3):305-18. doi:10.1007/s13555-017-0194-1.

  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.

  BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dr. Lyba Khan, FCPS, Fellowship in Derma

CONTACT

+923334400850; lybakhan95@gmail.com

Dr. Arfan ul Bari, FCPS Derma

CONTACT

+923016547007; albariul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluating dermatologist, assessing mMASI scores and photographs, will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups: topical 30% metformin vs Kligman's regimen for 8 weeks.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)