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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT04652232
Eligibility Criteria:
Selection criteria :
Criteria related to the population:
* Woman aged between 18 and 50 years old included
* Phototype I to IV included, according to Fitzpatrick classification
* Subject having signed written informed consent for the participation in the study
* Subject affiliated to a social security system or health insurance, or is a beneficiary of either (if required by national regulation)
* Subject whose last shampoo has been done at least 2 days before the selection visit
* Use of a contraceptive method assessed as efficient by an investigator (including tubal ligation), started since at least 3 months before the selection visit, continued during the study and until after 1 month after the study end
* Subject having hair length of at least 5 cm
Criteria related to diseases and hair loss disorder:
\- Subject having effluvium telogen
Non selection criteria :
Criteria related to the population:
* Pregnant or breastfeeding women or planning to being pregnant during the study
* Perimenopausal symptoms (irregular menstruations, premenstrual syndrome …) or menopausal symptoms (climacteric troubles: hot flush, headaches, tiredness, insomnia, irritability …)
* Menopause (absence of menstruations since at least 1 year) or a bilateral ovariectomy
* Subject having frizzy hair
* Subject who has forfeited her freedom by administrative or legal award or is under guardianship
* Subject who, according to the judgement of the investigator, is unlikely to be compliant during the study
* Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give her consent in writing to participate
* Subject who is currently participating in any another clinical trial
* Subject who has participated in another clinical trial with hair product or treatment (local on the scalp and/or systemic) within the last 12 weeks before the selection visit
Criteria related to diseases and hair loss disorders:
\- Subject who has any other hair disorder or hair disease (Ludwig II, III, AA, scarring alopecia …)
Criteria related to the population:
* Pregnant or breastfeeding women or planning to being pregnant during the study
* Perimenopausal symptoms (irregular menstruations, premenstrual syndrome …) or menopausal symptoms (climacteric troubles: hot flush, headaches, tiredness, insomnia, irritability …)
* Menopause (absence of menstruations since at least 1 year) or a bilateral ovariectomy
* Subject having frizzy hair
* Subject who has forfeited her freedom by administrative or legal award or is under guardianship
* Subject who, according to the judgement of the investigator, is unlikely to be compliant during the study
* Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give her consent in writing to participate
* Subject who is currently participating in any another clinical trial
* Subject who has participated in another clinical trial with hair product or treatment (local on the scalp and/or systemic) within the last 12 weeks before the selection visit
Criteria related to diseases and hair loss disorders:
* Subject who has any other hair disorder or hair disease (Ludwig II, III, AA, scarring alopecia …)
* History or clinical signs of hyperandrogenemia (menstrual cycle \>35 days and hirsutism and signs of acne)
* Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, etc.).
* Neoplastic disease at any time
* History of hypersensitivity or intolerance to any of the following components applied by topical route: ethyl alcohol, components of the used hair dye, components of the RV3466F lotion
* Thyroid disorders stabilised for less than 3 months
Criteria related to treatments and products:
* Systemic treatment affecting the hair growth taken for more than 4 weeks during the last 12 weeks before the selection visit:
* Finasteride
* Dutasteride
* Retinoids
* Anti-mitotic, cytotoxic drugs other than antineoplastic
* Spironolactone, flutamide, and all androgens
* Anti-epileptic agents, interferon alpha
* Minoxidil, Aminexil applied on the scalp within the last 24 weeks before the selection visit
* Systemic or local anti hair loss treatment or product, taken or applied (cosmetic solution or capsules with vitamin B, zinc, caffeine…) within the last 4 weeks before the selection visit.
* Drugs for thyroid disorders, if non stabilized for at least 3 months,
* Iron supplement if not started for at least 3 months
* Any hair care or styling method within the last week before the selection visit (e.g. dyeing, bleaching, perm, straightening, …)
* Any hair care product applied on the scalp between the last shampoo and the selection visit (e.g. gel, hairspray, wax, foam, …) or water or brushing.
* Any food supplements for hair growth taken for more than 4 weeks during the 12 weeks before the selection visit
* Radiotherapy, chemotherapy at any time
* Scalp surgery (hair transplants, laser) within the 12 months before the selection visit
Inclusion criteria :
* Criteria related to hair loss disorder:
* Subject having a proportion of hair in telogen phase superior to 15% (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
* Subject having a total hair density superior or equal to ≥ 220 hairs/ cm2 (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
Non inclusion criteria :
* Criteria related to treatments and products:
* Any hair care product applied on the scalp between the selection visit and the inclusion visit (e.g. gel, hairspray, wax, foam, …) or water or brushing.
* Reaction to the used hair dye during the inclusion visit
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04652232
Study Brief:
Protocol Section:
NCT04652232