Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital Karachi

January 19, 2026 updated by: Dr Summiya Shakeel Ahmed, Jinnah Postgraduate Medical Centre

Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital Karachi.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 7550
        • JPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18- 60 years of either gender.
  • Diagnosed with melasma based on clinical examination and Wood's lamp assessment.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients with a history of hypersensitivity to any study medication components.
  • Patients currently on other melasma treatments or those with other dermatologic conditions affecting pigmentation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (TRIPLE COMBINATION THERAPY GROUP)
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%)
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
Drug: Broad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Experimental: Group B ( METFORMIN 30% GEL THERAPY GROUP )
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: Broad-spectrum sunscreen (SPF ≥30)
Applied during daytime throughout the 12-week treatment period (both arms)
Drug: Metformin gel, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with ≥50% reduction in MASI score from baseline at 12 weeks.
Time Frame: 12 weeks (end of treatment)
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.
12 weeks (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in MASI score from baseline to 12 weeks.
Time Frame: 2 weeks (end of treatment)
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.
2 weeks (end of treatment)
Frequency of treatment-related adverse effects during the 12-week treatment period.
Time Frame: 12 weeks (during treatment)
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
12 weeks (during treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

August 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.2-81/2024-GENL/24/JPMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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