Actively Recruiting
COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
Led by Laboratoire Dermatologique ACM · Updated on 2025-08-20
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
L
Laboratoire Dermatologique ACM
Lead Sponsor
C
CIDP Mauritius
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 65 years
- Fitzpatrick skin phototype II to V
- Diagnosed mild to moderate epidermal or mixed-type facial melasma confirmed by Wood's lamp examination
- Baseline mMASI score between 3.5 and 13
- Generally good health based on medical history and exam
- Willing to avoid excessive sun exposure and only use provided SPF50+ sunscreen
- Able to understand study procedures and provide written consent
- Willing and able to comply with study procedures and visits
- Women of childbearing potential must use reliable contraception for at least 3 months before and during the study
You will not qualify if you...
- Presence of post-inflammatory hyperpigmentation, lentigines, or other non-melasma facial pigmentation
- Use of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks before baseline
- Allergy or hypersensitivity to any ingredients of study products
- Excessive sun exposure or tanning bed use within 2 weeks before baseline or planned during the study
- Active skin diseases or damaged skin in test areas
- Pregnant, breastfeeding, or planning pregnancy during the study
- Participation in another clinical trial within 4 weeks before or during this study
- History of malignancy in past 10 years except treated basal cell carcinoma
- Uncontrolled systemic illnesses such as diabetes, cardiovascular, hepatic, renal, or pulmonary diseases
- Psychological or cognitive conditions limiting ability to understand study procedures
- Current use of photosensitizing medications
- BMI over 40 or other conditions affecting protocol compliance as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre International de Développement Pharmaceutique
Port Louis, Phoenix, Mauritius, 73408
Actively Recruiting
Research Team
D
Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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