Biologics in Folliculitis Decalvans : an Adaptative Trial Research

NCT07268534 | Not Yet Recruiting Phase 2

• 2 other identifiers: APHP2308312024-514848-88-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Folliculitis Decalvans (FD)

Keywords

Folliculitis Decalvans; FD; alopecia; TNFa inhibitor; IL12 inhibitor; IL23 inhibitor; JAK1 inhibitor; JAK2 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

  At 6 month

Secondary Outcomes (8)

• Pain evaluated by Visual analogue Scale (VAS) at randomization, 3, 6 and 12 months

  at 3, 6 and 12 months

• Pain change from randomization, at 3, 6 and 12 months

  at 3, 6 and 12 months

• Pruritus evaluated by Worst Itch Numeric Rating Scale (WI-NRS) at randomization, 3, 6 and 12 months

  at 3, 6 and 12 months

• Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months

  at 3, 6 and 12 months

• Time to first relapse during the study period

  during the study period

Study Arms (3)

Investigational medicinal product 1

EXPERIMENTAL

1\) Adalimumab = TNFa inhibitor

Drug: Adalimumab

Investigational medicinal product 2

EXPERIMENTAL

2\) Ustekinumab = IL12 and 23 inhibitor

Drug: Ustekinumab

Investigational medicinal product 3

EXPERIMENTAL

3\) Baricitinib = inhibitor JAK 1 and JAK 2

Drug: Baricitinib

Interventions

Ustekinumab DRUG

For a 6-month duration

Investigational medicinal product 2

Baricitinib DRUG

For a 6-month duration

Investigational medicinal product 3

Adalimumab DRUG

For a 6-month duration

Investigational medicinal product 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Alopecia

Interventions

Adalimumab; Ustekinumab; baricitinib

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Bruno MATARD, Dr

CONTACT

01 58 41 17 81; bruno.matard@orange.fr

Olivier CHOSIDOW, Pr

CONTACT

01 42 16 31 31; olivier.chosidow@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: December 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share