COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS

Launched by LABORATOIRE DERMATOLOGIQUE ACM · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a new cosmetic serum works compared to a common skin-lightening cream that contains 4% hydroquinone, to treat melasma—a condition that causes dark patches on the face. The study will look at how much each product lightens the melasma after about 3 months (84 days) and how gentle they are on the skin. Researchers want to see if the cosmetic serum can improve the skin’s appearance as well as hydroquinone but with fewer side effects or irritation.

Adults aged 18 to 65 who have mild to moderate melasma confirmed by a special light test may be eligible to join. Participants will be assigned to one of two groups: one group will use the cosmetic serum along with sunscreen during the day and the serum plus a non-active cream at night, while the other group will use a placebo serum with sunscreen in the morning and the 4% hydroquinone cream at night. They will visit the clinic three times—at the start, around 8 weeks, and at the end—to check progress with photos, skin assessments by a doctor, and surveys about skin comfort and quality of life. People with certain skin conditions, allergies to the products, or who are pregnant won’t be able to participate. Throughout the study, participants must avoid excessive sun exposure and use the provided sunscreen.

Gender

ALL

Eligibility 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 4 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