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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT07268534
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18-year-old and \< 65-year-old
* Presenting with FD confirmed in all cases by at least one compatible histopathology (present or past)
* All patients should have a basal FD-IGA score at 3 or 4 and should have received in the previous 2 years at least two lines of antibiotics (first line : at least 3 months doxy/lymecycline (doxycycline 200 mg/day or at least 2 weeks, then 100 mg/day in the following weeks, or lymecycline 300 mg/day for at least 2 weeks, then 150 mg/day in the following weeks) ; second line : Rifampicin/clindamycin 10 weeks (classic regimen for FD) or, in case of contraindication or unaivailability of one or both of these drugs, other antibiotics prescribed for at least 3 weeks alone or in combination (list of antibiotics).
* Normal chest x-ray less than 3 months old on the day of inclusion
* Individuals affiliated to a social security regimen
* Individuals able to understand and express himself/herself in French
* Individuals able to participate and to follow up during the study period
* Written informed consent from the patient
The diagnosis of Folliculitis Decalvans must have been validated collectively as part of care with at least one FD expert.
Exclusion Criteria:
* Patients with a history of cardiac ischaemia
* Moderate to severe heart failure (NYHA classes III/IV)
As the whole treatment duration will only be 6 months, the risk of baricitinib-related SAEs will be minimized according to the recent PRAC from the EMA by excluding:
* Patients at increased risk of major cardio-vascular problem,
* Patients heavy smokers (25 cig/day),
* Current or past history of malignancy, with the exception of non-melanoma skin cancer excised and cured more than five years before baseline, per investigator assessment.
* Morbid obesity: BMI \> 40
* Individuals with known positive HIV tests and any immunosuppressive condition or drugs.
* Hypersensitivity to the active substance or to any of the excipients: Adalimumab, Ustekinumab, Baricitinib (see SmPC)
* Patient who has already received one of the treatments evaluated (Adalimumab, Ustekinumab, Baricitinib).
* Patient with renal insufficiency (creatinine clearance \< 60 mL/min)
* Coexisting inflammatory facial dermatosis such as acne fulminans, hidradenitis suppurativa
* Active tuberculosis or other severe infections such as sepsis and opportunistic infections
* Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures
* Individuals under a measure of legal protection or unable to consent
* Participation in another interventional study involving human participants or in the exclusion period at the end of a previous study involving human participants, if applicable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07268534
Study Brief:
Protocol Section:
NCT07268534