An interventional study of Metformin gel, 30% and Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) in Melasma, sponsored by Jinnah Postgraduate Medical Centre. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Jinnah Postgraduate Medical Centre · Not applicable, Interventional, and Health services research
This study will compare two topical treatments for melasma. Participants will be randomly assigned to receive either triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) or 30% metformin gel, applied once nightly for 12 weeks. All participants will use broad-spectrum sunscreen (SPF ≥30) during the daytime throughout the treatment period. Melasma severity will be assessed using the Melasma Area and Severity Index (MASI), and the study will determine which treatment is more effective and better tolerated at the end of 12 weeks.
This randomized, parallel-group clinical trial will be conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan, after approval from the Institutional Review Board/Ethics Committee of JPMC. Eligible patients presenting with clinically diagnosed melasma will be screened and enrolled after obtaining written informed consent.
Participants will be randomly assigned in a 1:1 ratio to one of two treatment arms using a computer-generated randomization sequence. Group A (active comparator) will receive topical triple combination cream containing hydroquinone 2%, tretinoin 0.025%, and fluocinolone acetonide 0.01%, applied once nightly to affected facial areas for 12 weeks. Group B (experimental) will receive topical metformin gel 30%, applied once nightly to melasma-affected areas for 12 weeks. All participants in both arms will be advised to apply broad-spectrum sunscreen (SPF ≥30) during daytime throughout the treatment period.
Melasma severity will be assessed using the Melasma Area and Severity Index (MASI) at baseline and during follow-up visits over the 12-week treatment period. The primary outcome will be the proportion of participants achieving at least a 50% reduction in total MASI score from baseline at week 12. Safety and tolerability will be monitored throughout the study by documenting adverse effects reported by participants or observed on clinical examination.
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 139 interventional studies indexed under Melanosis.
Browse Melanosis studies →Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) applied nightly for 12 weeks. All participants also used broad-spectrum sunscreen (SPF ≥30) during daytime.
Drug: Triple combination cream (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%) · Drug: Broad-spectrum sunscreen (SPF ≥30)
Participants will apply 30% metformin gel topically to melasma-affected areas once nightly for 12 weeks. All participants will also use broad-spectrum sunscreen (SPF ≥30) during daytime.
Drug: Metformin gel, 30% · Drug: Broad-spectrum sunscreen (SPF ≥30)
Participants will apply 30% metformin gel topically to melasma-affected areas once nightly for 12 weeks. All participants will also use broad-spectrum sunscreen (SPF ≥30) during daytime.
Topical triple combination cream containing hydroquinone 2%, tretinoin 0.025%, and fluocinolone acetonide 0.01%, applied once nightly to affected facial areas for 12 weeks
Applied during daytime throughout the 12-week treatment period (both arms)
Proportion of participants with ≥50% reduction in MASI score from baseline at 12 weeks.
The Melasma Area and Severity Index (MASI) will be used to assess the severity of melasma. The MASI score is calculated based on the area of involvement, darkness, and homogeneity on four facial regions. Participants achieving ≥50% reduction in total MASI score from baseline at week 12 will be classified as treatment responders. Data will be reported as the number and percentage of responders in each treatment arm and compared between arms.
Time frame: 12 weeks (end of treatment)
Mean change in MASI score from baseline to 12 weeks.
MASI score will be measured at baseline and at week 12. The mean change in MASI score from baseline to week 12 will be calculated for each treatment arm.
Time frame: 2 weeks (end of treatment)
Frequency of treatment-related adverse effects during the 12-week treatment period.
Adverse effects (e.g., erythema, burning, irritation, dryness) will be assessed and recorded at follow-up visits during the treatment period. Results will be summarized as the number and percentage of participants experiencing any adverse effect in each arm
Time frame: 12 weeks (during treatment)
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Jinnah Postgraduate Medical Centre