💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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