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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT07133334
Eligibility Criteria:
Inclusion Criteria:
* At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) \> 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (groups must be equilibrating);
* Patient with hair length \> 2 cm;
* Patient having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure;
* Patient usually using a shampoo 2 to 3 times a week and accepting to follow this rate during the whole study period;
* Patient having stopped any possible soothing, anti-dandruff and anti-hair loss treatment (per os or topical) 2 weeks prior to study beginning D-14;
* Patient agreeing not to use any other hair product other than the ones provided for the study (till the end of study) in particular:
* no styling product (tonic, spray, lotion, foam) three days before the study visit;
* no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil,….);
* no anti-scales products (whatever the type: shampoo, treatment..);
* no hair colouring or hair bleaching within one week prior to any study visit.
Exclusion Criteria:
* Subject with psoriasis;
* Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles;
* History of drug or alcohol abuse;
* History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment;
* Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before start of the study;
* Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study.
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol;
* Clinical signs and/or history of immunosuppression;
* Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris);
* Treatment with any other investigational drug in the 4 weeks prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07133334
Study Brief:
Protocol Section:
NCT07133334