COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS (NCT07071363) | Clinical Trial Compass
RecruitingNot Applicable
COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
Mauritius40 participantsStarted 2025-06-23
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Male or female subjects, primarily female, aged 18 to 65 years at the time of inclusion
Fitzpatrick skin phototype II to V
Diagnosed with mild to moderate epidermal or mixed-type facial melasma, confirmed by Wood's lamp examination
mMASI score between 3.5 and 13 at baseline
Subject is in general good health as assessed by the investigator based on medical history and clinical examination
Willing to avoid excessive sun exposure and use only the provided SPF50+ sunscreen during the study
Able to understand the study procedures and provide written informed consent
Willing and able to comply with study procedures and scheduled visits
Women of childbearing potential must agree to use a reliable method of contraception for at least 3 months prior to and during the entire study duration
Exclusion Criteria:
Presence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation
Use of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks prior to baseline
Known allergy or hypersensitivity to any component of the investigational or comparator products
Excessive sun exposure or use of tanning beds within 2 weeks before baseline or planned during the study
Active skin diseases (e.g., atopic dermatitis, psoriasis) or damaged skin in the test area
Pregnant or breastfeeding women, or those planning to become pregnant during the study
Participation in another cli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: 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.
Trial details
NCT IDNCT07071363
SponsorLaboratoire Dermatologique ACM
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2025-10-31
Contact for this trial
Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV)