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Study of ustekinumab, adalimumab, and baricitinib for patients with folliculitis decalvans that is difficult to treat

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with Folliculitis decalvans, which is a rare inflammatory condition of the scalp that causes scarring hair loss. The condition leads to patches of hair loss with pustules and crusting, and can cause pain and itching. This study is being conducted in patients whose condition has not responded well to at least two courses of antibiotic treatment. The study will test three different medications: baricitinib, which is taken as a tablet by mouth, adalimumab, which is given as an injection under the skin, and ustekinumab, which is also given as an injection under the skin. These medications work by targeting specific parts of the immune system that may be involved in causing the inflammation seen in this condition.

The purpose of this study is to find out which of these medications works best in reducing the severity of the condition in patients who have not improved with standard antibiotic treatments. The study will measure success by looking at whether there is a significant improvement in the severity of the disease after six months of treatment. This will be assessed using a scoring system that rates the overall appearance and severity of the condition, and the assessment will be done by someone who does not know which treatment the patient is receiving.

The study will last up to twelve months for each participant, with treatment being given for six months. During the study, patients will have regular visits to check how well the treatment is working and to monitor for any side effects. The study will also measure other important outcomes such as pain levels, itching, quality of life, and whether the condition comes back after treatment. If a patient's condition worsens significantly during the study, they may receive antibiotic treatment as a rescue therapy. Patients will need to have had a recent chest x-ray before starting the study, and they must be between eighteen and sixty-five years old to participate.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and treatment assignment

    At the start of the study, your condition will be assessed using the FD-IGA score, which is a rating scale that measures the severity of folliculitis decalvans. This assessment will be performed by an evaluator who does not know which treatment you are receiving.

    Your baseline FD-IGA score will be recorded as either 3 or 4, indicating moderate to severe disease activity.

    You will be assigned to receive one of the study medications: ustekinumab, adalimumab, or baricitinib.

  2. Step 2

    Treatment administration

    Depending on which medication you are assigned, you will receive treatment in one of the following ways:

    If assigned to ustekinumab: the medication will be administered as an injection under the skin.

    If assigned to adalimumab: the medication will be administered as an injection under the skin.

    If assigned to baricitinib: you will take Olumiant 4 mg tablets by mouth.

    The treatment will continue for a period of 6 months.

  3. Step 3

    Assessment at 3 months

    At 3 months after starting treatment, several assessments will be performed.

    Your pain level will be evaluated using a Visual Analogue Scale, where you will indicate your pain intensity on a scale.

    Your itching will be assessed using the Worst Itch Numeric Rating Scale, where you will rate the worst itching you have experienced.

    Your quality of life will be evaluated using the Dermatology Life Quality Index, a questionnaire that measures how your skin condition affects your daily life.

    Any side effects or problems with the medication will be recorded.

  4. Step 4

    Primary assessment at 6 months

    At 6 months after starting treatment, the main assessment of treatment effectiveness will be performed.

    Your FD-IGA score will be measured again by a blinded evaluator. Treatment will be considered successful if your score has decreased by at least 2 points compared to the beginning of the study.

    Your pain level will be evaluated again using the Visual Analogue Scale.

    Your itching will be assessed again using the Worst Itch Numeric Rating Scale.

    Your quality of life will be evaluated again using the Dermatology Life Quality Index.

    Any side effects or problems with the medication will be recorded.

  5. Step 5

    Final assessment at 12 months

    At 12 months after starting treatment, a final comprehensive assessment will be performed.

    Your FD-IGA score will be measured by a blinded evaluator.

    Your pain level will be evaluated using the Visual Analogue Scale.

    Your itching will be assessed using the Worst Itch Numeric Rating Scale.

    Your quality of life will be evaluated using the Dermatology Life Quality Index.

    Any side effects or problems with the medication will be recorded.

  6. Step 6

    Monitoring throughout the study

    Throughout the entire study period, you will be monitored for any relapse of your condition. A relapse means that your symptoms return or worsen after improving.

    If a relapse occurs, the time from the start of treatment to the relapse will be recorded.

    If needed, you may receive antibiotic rescue treatment during the study. If this occurs, your FD-IGA score will be measured at the time the antibiotic treatment begins.

    The total duration of your participation in the study will be 12 months.

Who can join the trial?

9 criteria

  • You must be 18 years old or older but younger than 65 years old
  • You must have a confirmed diagnosis of Folliculitis decalvans, which is a rare scalp condition that causes inflammation of hair follicles and scarring hair loss. This diagnosis must be confirmed by a tissue sample examination (a small piece of skin looked at under a microscope) either now or in the past, and the diagnosis must have been reviewed by at least one doctor who specializes in this condition
  • Your condition must be rated as moderate to severe (a score of 3 or 4 on a specific rating scale called FD-IGA, which measures how active and severe your condition is)
  • You must have already tried at least two different antibiotic treatments in the past 2 years. The first treatment should have been doxycycline or lymecycline (medicines that fight bacteria) taken for at least 3 months. The second treatment should have been a combination of rifampicin and clindamycin (two other antibiotics) taken for 10 weeks, or if you could not take these medicines, other antibiotics taken for at least 3 weeks
  • You must have a normal chest x-ray (a picture of your lungs and chest) taken within the last 3 months before joining the study
  • You must be enrolled in the French social security system (health insurance)
  • You must be able to understand and communicate in French
  • You must be able to participate in the study and attend all required visits during the study period
  • You must provide written informed consent, which means you agree in writing to participate in the study after understanding what it involves

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

Immunomodulatory targeted drugs are medications that work by adjusting how your immune system functions. These medicines help control the body's immune response, which may be overactive or not working properly in certain skin conditions. In this trial, these drugs are being tested to see if they can help improve a scalp condition called folliculitis decalvans by reducing inflammation and other immune system problems that contribute to the disease.

What is already known about the treatment

Immunomodulatory targeted drugs – These are medications that work by adjusting or modifying the body's immune system response, specifically targeting certain parts of the immune system rather than affecting it broadly. In this clinical trial, these drugs are being tested for their ability to treat folliculitis decalvans, a rare scalp condition that causes inflammation and permanent hair loss. The medications being studied belong to a group called biologics, which are made from living cells and work at the molecular level by blocking specific proteins or immune signals that cause inflammation and tissue damage. The trial aims to find out which of these targeted immune-modifying treatments can successfully reduce the severity of the disease in patients who have not responded well to standard treatments.

Investigated diseases

Folliculitis Decalvans – Folliculitis decalvans is a rare inflammatory condition that affects the scalp. It causes recurring bacterial infections of the hair follicles, leading to pustules, crusting, and inflammation. As the disease progresses, it destroys hair follicles, resulting in permanent hair loss in affected areas. The condition typically creates patches of scarring alopecia, where hair cannot regrow. Patients often experience pain and itching in the affected scalp areas. The disease tends to have a chronic course with periods of flare-ups and temporary improvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514848-88-00Protocol codeAPHP230831Estimated enrolment120 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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