Biologics in Folliculitis Decalvans : an Adaptative Trial Research

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07268534
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Folliculitis Decalvans (FD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Nov 2025
Primary completion
Nov 1, 2029
Completion
Apr 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational medicinal product 1
    1\) Adalimumab = TNFa inhibitor
  • Experimental: Investigational medicinal product 2
    2\) Ustekinumab = IL12 and 23 inhibitor
  • Experimental: Investigational medicinal product 3
    3\) Baricitinib = inhibitor JAK 1 and JAK 2

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 ]

Central Contacts