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MET-MEL
Comparison of Efficacy of Topical Triple Regimen Versus 30% Metformin in the Treatment of Epidermal Melasma
Sponsor study identifier
interventional
104
1 country
1
Study Start
August 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2026
Actual (reported)August 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 21, 2026
Actual (reported)January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of Participants Achieving at Least 25% Reduction in Modified Melasma Area and Severity Index (mMASI) Score
The modified Melasma Area and Severity Index (mMASI) score will be assessed at baseline and Week 8. Percentage reduction in mMASI score will be calculated as: \[(baseline mMASI score - Week 8 mMASI score) / baseline mMASI score\] × 100. A participant will be classified as a responder if the mMASI score decreases by at least 25% from baseline to Week 8. The outcome will be reported as the proportion of participants meeting this response criterion in each treatment group.
Baseline to 8 weeks
Participants assigned to this arm will apply topical 30% metformin cream once daily at night for eight consecutive weeks. Participants will also be advised to use SPF 50 or higher sunscreen in the morning.
Participants assigned to this arm will apply a topical triple regimen containing 2% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide once daily at night for eight consecutive weeks. Participants will also be advised to use SPF 50 or higher sunscreen in the morning.
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.
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.
Combined Military Hospital Malir
Karachi, Sindh, Pakistan
First Submitted
August 6, 2026
First Posted
August 21, 2026
Study Start
August 15, 2026
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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