Cosmetic serum versus 4% hydroquinone for treating facial melasma over 84 days
COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION
This trial tests whether a cosmetic depigmenting serum lightens mild-to-moderate facial melasma and is gentler on the skin than a 4% hydroquinone cream in adults 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laboratoire Dermatologique ACM Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Port Louis, Phoenix) |
| Trial ID | NCT07071363 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized, controlled trial compares an intensive anti-spot cosmetic serum (Depiwhite Serum) plus SPF50+ sunscreen with a 4% hydroquinone cream (Eldopinone) plus the same sunscreen over 84 days in adults with epidermal or mixed melasma. Participants are randomized to morning and evening regimens combining the serum or placebo and a high-protection sunscreen, with outcomes measured at baseline and day 84. Primary efficacy is change in modified Melasma Area and Severity Index (mMASI) and secondary endpoints include standardized ColorFace® photography with high-resolution colorimetric analysis and dermatologic tolerance under real-use conditions. The trial excludes other causes of facial pigmentation and recent depigmenting treatments to isolate effects on melasma.
Who should consider this trial
Good fit: Adults 18–65 with Fitzpatrick skin phototypes II–V and mild-to-moderate epidermal or mixed facial melasma (mMASI 3.5–13) who can use SPF50+ sunscreen and attend scheduled visits.
Not a fit: Patients with non-melasma facial pigmentation (post-inflammatory hyperpigmentation, lentigines), current use of topical or systemic depigmenting treatments, or who cannot attend the Mauritius site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the cosmetic serum could provide comparable lightening of melasma with fewer irritant side effects than 4% hydroquinone.
How similar studies have performed: 4% hydroquinone is an established standard for melasma, while multi-ingredient dermocosmetic serums have shown modest benefits in some trials but generally have less robust long-term evidence than hydroquinone.
Eligibility criteria
Show full inclusion / exclusion criteria
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 clinical trial within 4 weeks prior to the study or planned participation in another trial during the study History of malignancy in the past 10 years (except treated basal cell carcinoma) Uncontrolled systemic illness (e.g., diabetes, cardiovascular, hepatic, renal, or pulmonary disease) Any psychological or cognitive condition that would limit the subject's ability to understand the study procedures Current use of photosensitizing medications BMI \> 40 or other conditions that may affect protocol compliance as judged by the investigator
Where this trial is running
Port Louis, Phoenix
- Centre International de Développement Pharmaceutique — Port Louis, Phoenix, Mauritius (Recruiting)
Study contacts
- Study coordinator: Dr Gitanjali PETKAR Principal Investigator (Dermatologist), (MBBS, DDV)
- Email: g.petkar@cidp-cro.com
- Phone: +2304012600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.