Clinical Trial

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

Recruiting
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Record status
This record was last updated August 20, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-08.
Trial Details
NCT Number NCT07071363
Lead Sponsor Laboratoire Dermatologique ACM
Collaborators: CIDP Mauritius
Conditions Healthy, Melasma (Facial Melasma), Epidermal Melasma
Enrollment 40 participants
Start Date 2025-06-23
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-12-22 (estimated)
Updated on ClinicalTrials.gov 2025-08-20