Clinical Research Directory

Topical Metformin Versus Triple Regimen for Epidermal Melasma

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

COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS

The goal of this clinical trial is to compare the dermatological tolerance and skin-lightening efficacy of a cosmetic depigmenting serum to a 4% hydroquinone-based product in adult male and female subjects aged 18-65 years with mild to moderate epidermal or mixed-type melasma. The main questions it aims to answer are: Does the cosmetic serum reduce the severity of melasma (measured by mMASI) after 84 days of use? Is the cosmetic serum better tolerated than 4% hydroquinone under real-use conditions? Researchers will compare the serum group and the hydroquinone group to determine whether the cosmetic product achieves comparable pigmentation improvement with superior skin tolerability. Participants will: Group 1: Apply a morning routine (Depiwhite Serum + Depiwhite M SPF50+ cream) Apply an evening routine (Depiwhite Serum + Placebo Cream without Hydroquinone) Group 2: Apply a morning routine (Serum Placebo + Depiwhite M SPF50+ cream) Apply an evening routine (Serum Placebo + Depigmenting Cream with hydroquinone 4%) Visit the clinical site at baseline (Day 0), Day 56, and Day 84 for assessments Complete standardized photographs, self-assessment questionnaires, and quality-of-life surveys (MELASQoL and ASLQI) Undergo clinical evaluations by a dermatologist, including mMASI scoring and tolerance assessment