COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING 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
Laboratoire Dermatologique ACM
40 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria9
- 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 Criteria12
- 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
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Interventions
Participants 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07071363