COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaboratoire Dermatologique ACM
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Depigmenting Cosmetic Serum (Applied Morning and Evening)
DrugParticipants in Group 1 receive a depigmenting cosmetic serum with non-drug actives applied morning and evening, plus a placebo cream without hydroquinone applied in the evening. Group 2 receives a placebo serum (no active depigmenting ingredients) applied morning and evening, and a hydroquinone 4% cream applied in the evening. All participants apply an SPF50+ sunscreen in the morning throughout the 84-day study. The cosmetic serum is the investigational product; hydroquinone serves as the active comparator. Placebo products are visually matched to their respective actives to ensure blinding. The study distinguishes each intervention by active ingredients, timing of application (morning/evening), and role (test vs. reference vs. supportive care). All products are applied topically, and the regimen remains fixed across the study duration.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Depiwhite Serum + Placebo CreamExperimental treatment 1 intervention
Group B: Placebo Serum + Hydroquinone 4% CreamActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Modified Melasma Area and Severity Index (mMASI) Score From Baseline (Day 0) to Day 84 ±1 Day, Assessed by a Blinded Dermatologist to Evaluate the Clinical Efficacy of the Investigational and Comparator Products in Subjects With Melasma
The modified Melasma Area and Severity Index (mMASI) is a validated clinical scoring method used to assess the severity and extent of facial melasma. It evaluates four facial regions (forehead, right malar, left malar, and chin) based on the area of involvement and the intensity of pigmentation. Each region contributes proportionally to the total score, which ranges from 0 (no melasma) to 24 (severe melasma). In this study, the mMASI score will be assessed by a blinded dermatologist at baseline (Day 0) and again at Day 84 (±1 day). The primary objective is to quantify the change in mMASI score after 12 weeks of treatment with either the investigational cosmetic serum (Depiwhite Serum) or the comparator product containing hydroquinone 4% (Eldopinone). This outcome will serve as the primary measure of clinical efficacy in reducing melasma severity over the course of the study.
Time frame
Baseline (Day 0) to Day 84 ±1 day. The mMASI score will be assessed at both time points by a blinded dermatologist to evaluate the change in melasma severity over the 12-week treatment period.Secondary outcomes
1
Change in modified Melasma Area Severity Index (mMASI) at Day 56
Clinical evaluation of melasma severity on each hemi-face using the modified mMASI score, comparing baseline to Day 56. Unit of measure: Score(0-24)
Time frame
Day 562
Change in Individual Typology Angle (ITA°) from baseline
Evaluation of melasma pigmentation using ITA° from standardized ColorFace® photographs. Two Regions of Interest (ROI) are analyzed: one in melasma-affected skin and one in adjacent healthy skin. Unit of Measure: Degrees (°)
Time frame
Day 56 and Day 843
Change in Melasma Quality of Life Index (MELASQoL)
Subjects complete the MELASQoL questionnaire to evaluate the emotional and social impact of melasma. Unit of Measure: Score (7-70)
Time frame
Day 56 and Day 844
Subject-rated product efficacy and cosmetic acceptability
Subjects assess perceived product performance (e.g., brightness, evenness, spot reduction) and cosmetic acceptability using a structured questionnaire. Unit of Measure: Score on 4-point scale
Time frame
Day 28, Day 56, and Day 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laboratoire Dermatologique ACM
Lead sponsor
CIDP Mauritius
Collaborator
Source ClinicalTrials.gov