Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT05495503
Eligibility Criteria:
Inclusion Criteria:
* Female or male.
* African ethnicity
* Ages 18 to 65.
* Phototype V and VI according to Fitzpatrick scale
* Featuring brown spots (PIH) on the back ≥ 3 mm to ≤ 6 mm in diameter (at least 4 spots per subject).
* Agreeing not to be exposed to the sun (or artificial UV) during the study.
* Informed, having undergone a general clinical examination attesting to his ability to participate in the study.
* Having given written consent for participation in the study.
* No suspicion of carcinoma after investigation by a Dermatologist.
Exclusion Criteria:
* Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, UV ...) in the month before the start of the study, at the level of the back.
* Having applied a depilatory or exfoliating product in the month prior to the start of the study, at the level of the back.
* Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), at the level of the back in the last 6 months.
* With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...).
* Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics, anti-coagulants ...) likely to interfere with the evaluation of the parameter studied.
* Participating in another study or being excluded from a previous study.
* Unable to follow the requirements of the protocol.
* Vulnerable: whose ability or freedom to give or refuse consent is limited.
* Major protected by law (tutorship, curatorship, safeguarding justice...).
* People unable to read and write English language.
* Unable to be contacted urgently over the phone.
* Been on any other medication which may affect the outcome of the study or affect the skin condition in some way.
* Having ever undergone chemotherapy or other radiation treatment or received any prescription medication or medical treatment understood by them to affect the skin condition.
* Having any skin condition otherwise unsuitable for treatment in the opinion of the Investigator or clinician.
For female subjects:
* Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
* A woman, who does not use effective methods of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05495503
Study Brief:
Protocol Section:
NCT05495503