EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA (NCT06787846) | Clinical Trial Compass
CompletedNot Applicable
EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA
Brazil109 participantsStarted 2023-08-17
Plain-language summary
This study aims at assessing the non-inferiority of tested formula facial serum (2039125 03) versus hydroquinone 4% over 3 months for treatment and then 3 months for maintenance ofwomen subjects presenting facial melasma.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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✓. Melasma epidermal or mixed (exclude dermal melasma);
✓. Ready to protect as much as possible from the sun for the duration of the study;
✓. Ready to avoid contraindicated products (irritants, other depigmenting agents);
✓. Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form.
Exclusion criteria
✕. Subjects with dermal melasma (wood lamp at inclusion);
✕. Subjects who has already use of hydroquinone 4% in the past year;
✕. Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
✕. Pregnant or breastfeeding women or pregnancy plans;