Melasma30% Topical Metformin vs. Kligman's Regimen for Melasma in Middle-Aged Women
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.
Topical 30% metformin cream
+ Kligman's Regimen
Melanosis+2
+ Pigmentation Disorders
+ Skin Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.82 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Fauji Foundation Hospital, Rawalpindi
Rawalpindi, PakistanOpen Fauji Foundation Hospital, Rawalpindi in Google Maps