New hope for rare scalp disease: biologics aim to stop painful flares and hair loss
NCT ID NCT07268534
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests biologic drugs for folliculitis decalvans, a rare scalp disease that causes painful pustules and permanent hair loss. Current antibiotics only work about half the time and the condition often returns. The trial will enroll 120 adults who have already tried at least two antibiotic treatments, and will measure if biologics can reduce disease severity over 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.