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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07292467
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 (The groups must be balanced to ensure an equitable distribution)
* All types of scalp.
* Any phototype
* Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
* Severe itching score ≥ 7
* Subject with hair length \> 2 cm.
* Subject 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.
* Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.
* Subject 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 coloring or hair bleaching within one week prior to any study visit.
* Subject agreeing not to have a short haircut during the entire study period.
* Subjects in good general and mental health in the opinion of the investigator
* Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form
* Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
Exclusion Criteria:
* Subject with scalp psoriasis
* Subject with more than 60% of white hair influencing the scoring of scales.
* Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
* Subject with alopecia in vertex (stage \> IIIa Hamilton and \> I Ludwig)
* Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
* Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.
* Subject with history of allergy and/or reactions to latex.
* Subject who has taken:
* Corticoids (local or per os) within 2 weeks before the study entry
* Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,
* retinoid acid (local or per os) since less than 6 months before study entry.
* Subject practicing regularly water sport and/or having regular sauna sessions.
* Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).
* Pregnancy, breastfeeding, 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 the start of the study.
* Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study
* Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
* 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 pectoris)
* Treatment with any other investigational drug in the 4 weeks prior to study entry
* Employee of the sponsor or the study site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07292467
Study Brief:
Protocol Section:
NCT07292467