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Topical Metformin Versus Triple Regimen for Epidermal Melasma

NCT07779811 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-21

No results posted yet for this study

Summary

Melasma is a common skin condition that causes dark brown patches, mainly on sun-exposed areas of the face. It is often persistent, may recur after treatment, and can affect a person's quality of life. The standard topical triple regimen used for melasma contains hydroquinone, tretinoin, and fluocinolone acetonide. Although effective, prolonged use may cause adverse effects such as redness, burning, peeling, telangiectasia, and steroid-related skin changes. Topical metformin has recently been investigated as a possible alternative treatment because it may reduce skin pigmentation with relatively few side effects.

This randomized clinical trial will compare the efficacy of topical 30% metformin cream with a topical triple regimen in adults with epidermal melasma. A total of 104 participants aged 18-50 years will be enrolled, with 52 participants assigned to each treatment group. Group A will receive topical 30% metformin, while Group B will receive a triple regimen containing 2% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide. Participants will apply the assigned treatment once daily at night for eight consecutive weeks. All participants will also be advised to use SPF 50 or higher sunscreen in the morning.

Treatment efficacy will be assessed by comparing the modified Melasma Area and Severity Index score at baseline and after eight weeks. Treatment will be considered effective when the participant achieves at least a 25% reduction in the modified MASI score from baseline. The findings may help identify a more effective and acceptable topical treatment option for patients with epidermal melasma

Conditions

  • Epidermal Melasma
  • Facial Hyperpigmentation

Interventions

DRUG

Topical 30% metformin cream

Topical metformin cream at a concentration of 30% will be applied once daily at night to affected facial areas for eight consecutive weeks. Participants will use SPF 50 or higher sunscreen in the morning.

DRUG

Topical Triple Regimen

A topical triple-combination regimen containing 2% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide will be applied once daily at night to affected facial areas for eight consecutive weeks. Participants will use SPF 50 or higher sunscreen in the morning.

Sponsors & Collaborators

  • Combined Military Hospital, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-01-15
Completion
2027-01-30

Countries

  • Pakistan

Study Locations

More Related Trials

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 NCT07779811 on ClinicalTrials.gov