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Biologics in Folliculitis Decalvans : an Adaptative Trial Research

NCT07268534 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-05

No results posted yet for this study

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)

Interventions

DRUG

Adalimumab

For a 6-month duration

DRUG

Ustekinumab

For a 6-month duration

DRUG

Baricitinib

For a 6-month duration

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-11-01
Completion
2030-04-01

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268534 on ClinicalTrials.gov