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 range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Women;
. Adults (over 18 y.o.) (preference 18-50 y.o.);
. Phototypes I to IV;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mMASI scoring

Timeframe: From baseline to 3months

Evaluation of Global Tolerance

Timeframe: From 1month to 3 months

Trial details

NCT IDNCT06787846

SponsorCosmetique Active International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-12

View on ClinicalTrials.gov More Melasma trials