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Official title COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
ClinicalTrials.gov ID: NCT07071363
What this study is testing
What is Depigmenting Cosmetic Serum (Applied Morning and Evening)?
Depigmenting Cosmetic Serum (Applied Morning and Evening) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for healthy.
Also referred to as Hydroquinone 4% Cream (Applied in the Evening), Placebo Serum (Applied Morning and Evening).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female people, 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
You likely can't join if
- 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
See the full eligibility criteria
- Male or female people, 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Port Louis, Phoenix, Mauritius
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Port Louis, Phoenix, Mauritius. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.