Cosmetic serum versus 4% hydroquinone for treating facial melasma over 84 days

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.