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Melasma30% Topical Metformin vs. Kligman's Regimen for Melasma in Middle-Aged Women

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Study Aim

This study compares the effectiveness of 30% Topical Metformin and Kligman's Regimen in reducing melasma symptoms in middle-aged women, measured by the modified MASI score over an 8-week period.

What is being tested

Topical 30% metformin cream

+ Kligman's Regimen

Drug
Who is being recruted

Melanosis+2

+ Pigmentation Disorders

+ Skin Diseases

From 35 to 55 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2026
See protocol details

Summary

Principal SponsorFoundation University Islamabad
Study ContactDr. Lyba Khan, FCPS, Fellowship in DermaMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

Melasma is a skin condition that causes brown patches on the face, primarily affecting middle-aged women. This study is about finding a new approach to manage melasma, comparing the effectiveness of a topical cream containing 30% metformin and the current standard treatment known as Kligman's regimen. The goal is to see if metformin, an antidiabetic drug with antioxidant and anti-pigment properties, can offer a safer and equally effective alternative for treating melasma. The study specifically targets middle-aged women with epidermal melasma, aiming to improve care and address the challenges associated with current treatments. Participants in this study will be divided into two groups. One group will apply the 30% metformin cream once every night, while the other will use Kligman's regimen in the same manner. The study will last for 8 weeks, during which the effectiveness of each treatment will be evaluated using the modified Melasma Area and Severity Index (mMASI) score. This score measures the size and darkness of pigmentation on different parts of the face. The study will also monitor any side effects such as redness, burning, irritation, peeling, or skin discoloration. The hypothesis is that topical 30% metformin may be more effective than Kligman's regimen in reducing mMASI score after 8 weeks.

Official TitleA Novel Approach to Melasma Management: Comparative Evaluation of Topical 30% Metformin and Kligman's Regimen in Middle-Aged Women
Principal SponsorFoundation University Islamabad
Study ContactDr. Lyba Khan, FCPS, Fellowship in DermaMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 35 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanosisPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesHyperpigmentation

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
Pregnancy or lactation

Known allergy to study medications

Active facial dermatitis, acne, or recent cosmetic procedures

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, PakistanOpen Fauji Foundation Hospital, Rawalpindi in Google Maps
Recruiting soonOne Study Center
Melasma | 30% Topical Metformin vs. Kligman's Regimen for Melasma in Middle-Aged Women | PatLynk