Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma (NCT06516224) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Brazil150 participantsStarted 2024-07-15
Plain-language summary
This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.
Who can participate
Age range
18 Years – 65 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:
* 18-65 years
* Phototype II-V
* 50% with sensitive skin (declarative);
* Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year
Exclusion Criteria:
* Subjects under topical or systemic retinoids;
* Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;
* Subjects under systemic immunosuppressants and considered immune compromised
* Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months
* Pregnant women and/or breastfeeding women
* Subjects with a recent change in contraception (since less than 6 months);
* Subjects known allergy to any component of tested product;
* Subjects not presenting with the conditions needed to comply with the protocol;
* Subjects without any other dermatological conditions on the face
* Subject under menopause phase with hormonal replace therapy
* Subjects in the initial phase, change or discontinuation of hormonal treatment (estroprogesterone, cyproteron acetate, androgenic...) in the last 3 months;
* Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
* Subjects unable to give their informed consent.
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.