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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT06854432
Eligibility Criteria:
Selection criteria:
Criteria related to the population:
* Male
* Subject aged between 30 and 50 years included
Criteria related to the scalp condition:
* Subject with hair length over 3 cm
* Subject presenting a negative pull test result
Specific for non-AGA group:
• Non-alopecic men with full head of hair with uniform scalp coverage (homogeneous hair density on the vertex, occiput, left and right parietal areas)
Specific for AGA group:
• Androgenetic alopecic men with progressive AGA for more than 5 years: stage between III to IV included according to the Hamilton's classification modified by Norwood
Non-selection criteria:
Criteria related to the population:
* Subject having received on study areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 months before the selection visit
* Subjects with frizzy hair
Criteria related to diseases:
* Subject having neoplastic disease (history of disease or disease on-going)
* Subject having severe acute progressive disease (infectious syndromes, inflammatory, COVID-19, acute fever...) occurred within the last 3 months before the selection visit liable to interfere with the study assessments
* Subject with iron deficiency on-going, not treated or treated for less than 3 months before the selection visit
* Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements
Specific for non-AGA group:
* Subject with any type of alopecia
* Subject with family history of androgenetic alopecia in the father with stage ≥ III according to the Hamilton's classification modified by Norwood
Specific for AGA group:
• Subject with non-androgenetic alopecia (Cicatricial alopecia, Alopecia aerata...)
Criteria related to procedures, treatments, products and/or hair care routine:
* Radiotherapy, chemotherapy
* Scalp surgery
* Systematic or local androgenetic alopecia treatment or product, taken or applied for more than 4 consecutive weeks during the last 6 months before the selection visit
* Any following hair care within the last 3 months before the selection visit: dyeing, bleaching, perm
* Systemic or local non-steroidal anti-inflammatory drug taken or applied on the scalp for more than 1 week during the last month (systematic NSAIDs) or 2 weeks (local NSAIDs) before the selection visit
Non-inclusion criteria:
Criteria related to the population:
* Subject having received on study areas artificial UV exposure, excessive or prolonged exposure to natural sunlight between selection and inclusion visit
Criteria related to the disease:
• Subject with any adverse event occurring between selection and inclusion visit liable to interfere with the study assessments
Criteria related to treatments and/or products:
• Any procedures, treatments, products and/or hair care taken, applied or performed between selection and inclusion visit liable to interfere with the study assessments
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT06854432
Study Brief:
Protocol Section:
NCT06854432