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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT04865120
Eligibility Criteria:
Inclusion Criteria:
* Healthy female or male volunteer;
* from 18 to 40 years old;
* uniform skin color all over on the investigational zones;
* skin type III or IV according to the Fitzpatrick classification;
* ITA° between 10° and 35° at screening visit with an authorize delta of ± 2° at inclusion visit (D1) (Individual Typologic Angle calculated value);
* female of childbearing age using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
* informed about the study objectives and procedures, and able to understand them;
* willing and able to fulfill the study requirements and schedule.
* All subjects will have to give their written informed consent.
Exclusion Criteria:
* Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ;
* having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
* having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion;
* having sunburn (erythema) on the back;
* dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
* history of skin cancer;
* history of abnormal response to sun;
* presence of recent suntan (according to Investigator opinion) or photo-test marks;
* history of allergy, hypersensitivity, or any serious reaction to any cosmetic product;
* any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
* having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-), or any medication known to cause abnormal responses to U.V. exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study;
* having used within the 3 months before inclusion any depigmenting / whitening or propigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (antiinflammatory drugs, corticoids, retinoids, hydroquinone, etc.);
* unable to be contacted by phone in case of emergency;
* having participated within the 30 days before inclusion or currently participating in another clinical study.
* Deprived of liberty by adjunction or by official decision.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04865120
Study Brief:
Protocol Section:
NCT04865120