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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT04237402
Eligibility Criteria:
Inclusion Criteria:
Criteria related to the Population:
* Pregnant woman (≥ 33 weeks of amenorrhea)
* Woman aged between 18 and 40 years (included)
* Phototype I to IV included according to Fitzpatrick's classification
* Affiliation to a French social security scheme or benefiting from such a scheme
* Signed informed consent form
Exclusion Criteria:
Criteria related to the Population:
* High risk or pathological pregnancy, according to the opinion of the investigator
* Deprivation of liberty by administrative or judicial decision or subject under guardianship
* Impossibility, according to the investigator, to comply with the requirements of the protocol
* Linguistic or psychic incapacity to sign informed consent
* Concomitant participation in a clinical study that may interfere with the results of the study, according to the opinion of the investigator (excluding observational studies)
Criteria related to Pathology :
* Alopecia causing hair loss on the upper part of the scalp
* Dermatological pathology or evolving cutaneous lesion in the scalp
* Known history of hepatitis B and C, HIV
* Past or present neoplastic condition
* Acute evolving pathology
* Gestational diabetes treated with insulin
Criteria related to Treatments:
* Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion (or change of specialty for less than 3 months)
* Systemic treatment affecting hair growth taken for at least 4 weeks during the 3 months prior to inclusion
* Systemic treatment: nonsteroidal anti-inflammatory drug, corticosteroid, antibiotic, antihistamine taken for 5 consecutive days within 2 weeks prior to inclusion or that may interfere with the results of the study according to the investigator,
* Dermal use, for at least 4 weeks, of Minoxidil, Aminexil within 3 months prior to inclusion
* Dermal use in the 4 weeks prior to inclusion, of any product that may be active on the hair follicle and scalp or may affect the dosage of carbonyl compounds (including hair dyes)
* Last shampoo less than 2 days before the inclusion and application of styling / care products (gel, lacquer, wax, conditioner ...) or water between the last shampoo and the inclusion
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04237402
Study Brief:
Protocol Section:
NCT04237402