Folliculitis Decalvans (FD)Phase 2BOOSTERSNCT07268534
Biologics in Folliculitis Decalvans : an Adaptative Trial Research
A Phase 2 study testing Adalimumab, Ustekinumab and Baricitinib in people with Folliculitis Decalvans (FD), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
FD (which was in the past named Quinquaud folliculitis) is a rare disease defined by a chronic, neutrophilic folliculitis of the scalp, leading to scarring alopecia. During the flares, scabs and pustules, sometimes very extensive and painful, induce definitive alopecia with quality of life is considerably impaired. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Folliculitis Decalvans (FD)
- What is being tested?
- Adalimumab, Ustekinumab and Baricitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
FD (which was in the past named Quinquaud folliculitis) is a rare disease defined by a chronic, neutrophilic folliculitis of the scalp, leading to scarring alopecia. During the flares, scabs and pustules, sometimes very extensive and painful, induce definitive alopecia with quality of life is considerably impaired. Pathophysiology remains unclear although the cutaneous microbiota with a rupture of the epidermal barrier, leading to pathogen invasion, most often Staphylococcus aureus (SA), has been involved.It explains why first-line treatment of FD is antibiotics, i.e., oral tetracycline/doxycycline (combined with topical antibiotics) for 3 months at least. Second-line treatment includes an association of antibiotics, e.g., rifampicin-clindamycin for 10-12 weeks or, in case of contraindication or unavaibility of one or both of these drugs, other antibiotics listed.
Short-term efficacy rate of antibiotics is around 50-60%, but unfortunately, recurrences/relapses are occurring 5 to 7 months on average after stopping antibiotics, requiring their reintroduction/long-term use and potentially less efficacy/ecological harms. So far, FD is a non-curable disease for which inflammatory pathways involving several cytokines as TNF, IL1β, IL8, TGFβ, IL12 and 23, could also play a role.
Read the detailed description
Folliculitis Decalvans (FD) is a rare disease defined by a chronic, neutrophilic folliculitis of the scalp, leading to scarring alopecia. During the flares, scabs and pustules, sometimes very extensive and painful, induce the definitive alopecia. As expected, quality of life is heavily impaired. Pathophysiology remains unclear although the microbiota with a rupture of the epidermal barrier, leading to pathogen invasion, most often Staphylococcus aureus (SA), has been involved. It explains why first-line treatment of FD is antibiotics, i.e., oral tetracycline / doxycycline (combined with topical antibiotics) for 3 months at least. Second-line treatment includes an association of antibiotics, e.g., rifampicin-clindamycin for 10-12 weeks.
Short-term efficacy level of antibiotics is around 50-60% but unfortunately, recurrences/relapses are occurring 5 to 7 months after stopping antibiotics on average, requiring their reintroduction/long-term use and potentially less efficacy. So far, FD is a non-curable disease for which inflammatory pathways involving several cytokines as TNF, IL1β, IL8, TGFβ, IL12, IL 23, could also play a role. The similarity of FD with hidradenitis suppurativa (HS) suggests a double approach based on antibiotics and immunomodulatory targeted drugs. Only short series have been reported in attempting to control the inflammatory response by biologic agents, including anti-TNF, anti-IL12 and IL23, JAK inhibitors. Although several cures of antibiotics could be delivered lifelong, it may impair the microbiota at the individual and populational levels with known (and possibly still unknown) ecological consequences. With regards to limited available treatment, potential harms of antibiotics, and absence of therapeutic strategy, any new treatment able to control signs and symptoms of flare of FD in patients previously treated by 2 lines of antibiotics - so called difficult-to- treat patients - could be used in a forthcoming strategy.
We hypothesized that targeted therapies as biologics could control a flare of FD in difficult-to-treat patients with a relevant response. With regards to the literature, this approach would allow a new clue in the management of FD.
- Conditions
- Folliculitis Decalvans (FD)
- Being tested
- Adalimumab, Ustekinumab, Baricitinib
- Keywords
- Folliculitis Decalvans, FD, alopecia, TNFa inhibitor, IL12 inhibitor, IL23 inhibitor, JAK1 inhibitor, JAK2 inhibitor
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
For a 6-month duration
UstekinumabDrug
For a 6-month duration
BaricitinibDrug
For a 6-month duration
| Study group | Role | What they receive |
|---|---|---|
| Investigational medicinal product 1 | Experimental | 1) Adalimumab = TNFa inhibitor Receives: Drug: Adalimumab |
| Investigational medicinal product 2 | Experimental | 2) Ustekinumab = IL12 and 23 inhibitor Receives: Drug: Ustekinumab |
| Investigational medicinal product 3 | Experimental | 3) Baricitinib = inhibitor JAK 1 and JAK 2 Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 month
Measured: At 6 month
Secondary outcomes (8)
Pain evaluated by Visual analogue Scale (VAS) at randomization, 3, 6 and 12 months
Measured: at 3, 6 and 12 months
Pain change from randomization, at 3, 6 and 12 months
Measured: at 3, 6 and 12 months
Pruritus evaluated by Worst Itch Numeric Rating Scale (WI-NRS) at randomization, 3, 6 and 12 months
Measured: at 3, 6 and 12 months
Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months
Measured: at 3, 6 and 12 months
Time to first relapse during the study period
Measured: during the study period
Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue)
Measured: at the onset of the rescue
Measure of FD-IGA score (blinded assessor) at 12 months
Measured: at 12 months
Tolerance of drugs
Measured: during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folliculitis Decalvans (FD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a national multicenter, randomized, not controlled single-blind, phase II clinical study.The study will be considered in a general Bayesian framework. The design is not conceived for between-group comparisons but to potentially individualize promising treatment allowing early stop of treatment based on unacceptable posterior probability of success.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268534
- Sponsor's protocol ID
- APHP230831
- Other IDs
- 2024-514848-88-00
- Acronym
- BOOSTERS
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologics in Folliculitis Decalvans : an Adaptative Trial Research
- ClinicalTrials.gov ID
- NCT07268534
- Acronym / sponsor ID
- BOOSTERS / APHP230831
- Conditions
- Folliculitis Decalvans (FD)
- Keywords
- Folliculitis Decalvans, FD, alopecia, TNFa inhibitor, IL12 inhibitor, IL23 inhibitor, JAK1 inhibitor, JAK2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FD (which was in the past named Quinquaud folliculitis) is a rare disease defined by a chronic, neutrophilic folliculitis of the scalp, leading to scarring alopecia. During the flares, scabs and pustules, sometimes very extensive and painful, induce definitive alopecia with quality of life is considerably impaired. Pathophysiology remains unclear although the cutaneous microbiota with a rupture of the epidermal barrier, leading to pathogen invasion, most often Staphylococcus aureus (SA), has been involved.It explains why first-line treatment of FD is antibiotics, i.e., oral tetracycline/doxycycline (combined with topical antibiotics) for 3 months at least. Second-line treatment includes an association of antibiotics, e.g., rifampicin-clindamycin for 10-12 weeks or, in case of contraindication or unavaibility of one or both of these drugs, other antibiotics listed.
Short-term efficacy rate of antibiotics is around 50-60%, but unfortunately, recurrences/relapses are occurring 5 to 7 months on average after stopping antibiotics, requiring their reintroduction/long-term use and potentially less efficacy/ecological harms. So far, FD is a non-curable disease for which inflammatory pathways involving several cytokines as TNF, IL1β, IL8, TGFβ, IL12 and 23, could also play a role.
Detailed description
Folliculitis Decalvans (FD) is a rare disease defined by a chronic, neutrophilic folliculitis of the scalp, leading to scarring alopecia. During the flares, scabs and pustules, sometimes very extensive and painful, induce the definitive alopecia. As expected, quality of life is heavily impaired. Pathophysiology remains unclear although the microbiota with a rupture of the epidermal barrier, leading to pathogen invasion, most often Staphylococcus aureus (SA), has been involved. It explains why first-line treatment of FD is antibiotics, i.e., oral tetracycline / doxycycline (combined with topical antibiotics) for 3 months at least. Second-line treatment includes an association of antibiotics, e.g., rifampicin-clindamycin for 10-12 weeks.
Short-term efficacy level of antibiotics is around 50-60% but unfortunately, recurrences/relapses are occurring 5 to 7 months after stopping antibiotics on average, requiring their reintroduction/long-term use and potentially less efficacy. So far, FD is a non-curable disease for which inflammatory pathways involving several cytokines as TNF, IL1β, IL8, TGFβ, IL12, IL 23, could also play a role. The similarity of FD with hidradenitis suppurativa (HS) suggests a double approach based on antibiotics and immunomodulatory targeted drugs. Only short series have been reported in attempting to control the inflammatory response by biologic agents, including anti-TNF, anti-IL12 and IL23, JAK inhibitors. Although several cures of antibiotics could be delivered lifelong, it may impair the microbiota at the individual and populational levels with known (and possibly still unknown) ecological consequences. With regards to limited available treatment, potential harms of antibiotics, and absence of therapeutic strategy, any new treatment able to control signs and symptoms of flare of FD in patients previously treated by 2 lines of antibiotics - so called difficult-to- treat patients - could be used in a forthcoming strategy.
We hypothesized that targeted therapies as biologics could control a flare of FD in difficult-to-treat patients with a relevant response. With regards to the literature, this approach would allow a new clue in the management of FD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a national multicenter, randomized, not controlled single-blind, phase II clinical study.The study will be considered in a general Bayesian framework. The design is not conceived for between-group comparisons but to potentially individualize promising treatment allowing early stop of treatment based on unacceptable posterior probability of success.
| Arm | Type | Receives |
|---|---|---|
| Investigational medicinal product 1 | Experimental | Drug: Adalimumab1) Adalimumab = TNFa inhibitor |
| Investigational medicinal product 2 | Experimental | Drug: Ustekinumab2) Ustekinumab = IL12 and 23 inhibitor |
| Investigational medicinal product 3 | Experimental | Drug: Baricitinib3) Baricitinib = inhibitor JAK 1 and JAK 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabFor a 6-month duration | Drug | Investigational medicinal product 1 |
| UstekinumabFor a 6-month duration | Drug | Investigational medicinal product 2 |
| BaricitinibFor a 6-month duration | Drug | Investigational medicinal product 3 |
Primary outcome
The primary end point is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 month
Time frame: At 6 month
8 secondary outcomes
Pain evaluated by Visual analogue Scale (VAS) at randomization, 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Pain change from randomization, at 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Pruritus evaluated by Worst Itch Numeric Rating Scale (WI-NRS) at randomization, 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Time to first relapse during the study period
Time frame: during the study period
Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue)
Time frame: at the onset of the rescue
Measure of FD-IGA score (blinded assessor) at 12 months
Time frame: at 12 months
Tolerance of drugs
Time frame: during the study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab, Ustekinumab and Baricitinib in people with Folliculitis Decalvans (FD), run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno MATARD, Dr (01 58 41 17 81, bruno.matard@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 month (time frame: At 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.