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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05322668
Eligibility Criteria:
Inclusion Criteria:
* Female or male.
* Ages \> 18.
* Phototype V et VI (according with Fitzpatrick scale)
* Agreeing not to be exposed to the sun (or artificial UV) during the study.
* Informed, having undergone a general clinical examination attesting to his/her 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, facials, UV ...) in the month before the start of the study, at the level of the hand.
* Having applied a depraving product in the month prior to the start of the study, at the hands (except cleansing products).
* Having performed cosmetic treatments in a dermatologist (laser, IPL (Intensed pulsed light), peeling, creams, cryotherapy ...), on the hands 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 ...) 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 understand, read and write English/French/Ukrainian language. However, the impartial witness will be introduced to current study to make translations if necessary, during all course of the study for each volunteer and respective section for signature and date will be implemented to the "Information Sheet and Informed Consent Form".
* Unable to be contacted urgently over the phone.
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:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05322668
Study Brief:
Protocol Section:
NCT05322668