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BOOSTERS: Biologics in Folliculitis Decalvans

NCT07268534Phase 2

Key facts

Status: Not yet recruiting
Start: Apr 2026
Primary completion: Nov 2029
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Small Molecules, Recombinant Proteins and Enzymes, Monoclonal Antibodies

Drugs: adalimumabustekinumabbaricitinib
Conditions: Folliculitis decalvans (FD)

Overview

Phase 2, randomised, single-blind trial in Folliculitis decalvans (FD) comparing Adalimumab, Ustekinumab and Baricitinib (3 arms). Primary endpoint: Folliculitis Decalvans Investigator Global Assessment at 6 months. Planned start Apr 2026; status: not yet recruiting.

Design

3 arms

Study design: RandomizedSingle-blind

Adalimumab
Adalimumab for 6 months
Ustekinumab
Ustekinumab for 6 months
Baricitinib
Baricitinib for 6 months

Who it enrols

Adults aged 18-64 with confirmed Folliculitis Decalvans, a basal FD-IGA score of 3 or 4, and prior failure of at least two lines of antibiotics. Excludes patients with significant cardiovascular risk, heavy smokers, history of malignancy, morbid obesity, HIV, renal insufficiency, or active severe infections.

Endpoints

Primary

Folliculitis Decalvans Investigator Global Assessment6 months

Secondary

Pain Visual Analogue Scale12 months
Worst Itch Numeric Rating Scale12 months
Dermatology Life Quality Index12 months
Time to first relapseup to 12 months
Folliculitis Decalvans Investigator Global Assessment at antibiotic rescueat onset of rescue
Folliculitis Decalvans Investigator Global Assessment at 12 months12 months
Tolerance of drugsup to 12 months

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