AuthorisedTherapeutic exploratory (Phase II)Interventional

BOOSTERS - BiOlogics in FOlliculitis decalvanS : an adaptaTivE tRial reSearch

This study, called BOOSTERS, is exploring new ways to treat folliculitis decalvans. This is a skin condition that affects the scalp, leading to painful sores and permanent hair loss. Researchers are testing different medications, including Adalimumab, Ustekinumab, and Olumiant, to see how well they work. The main goal is to find out if these medicines can significantly improve the condition after six months, meaning fewer and less severe scalp problems. They also want to understand if these treatments help with pain, itching, and overall quality of life. This is a Phase II study, which means it's an earlier stage of drug development, looking at safety and how effective the treatments might be.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

120

Start

24 Nov 2025

Folliculitis decalvans

What is this study about?

Folliculitis decalvans is a type of skin condition that affects your scalp. It causes painful, inflamed sores that can lead to permanent hair loss and scarring. It can be quite uncomfortable and bothersome. This study, called BOOSTERS, is looking into new ways to help people living with this condition.

Researchers are testing a few different medications – Adalimumab, Ustekinumab, and Olumiant – to see which ones might be most effective. These types of medicines are sometimes called 'biologics' and they work by targeting specific parts of the immune system that might be overactive in conditions like folliculitis decalvans. The main aim is to see if these treatments can significantly reduce the severity of the scalp condition after six months. This would mean fewer sores and less inflammation, leading to a much better experience for those affected.

Beyond just looking at the skin, the study also wants to understand how these treatments impact other important aspects of life. This includes checking if the medicines help reduce pain and itching, which can be big problems for people with this condition. They'll also look at how much the treatments improve day-to-day life and overall well-being. By doing this, the researchers hope to find better ways to manage folliculitis decalvans and improve the quality of life for people who have it.

Key takeaways

This study evaluates new treatments for folliculitis decalvans.
It aims to improve scalp condition, reduce pain, and enhance quality of life.
Treatments include medications like Adalimumab, Ustekinumab, and Olumiant.
Participation involves regular visits and assessments over 12 months.
You might gain access to new treatments before they are widely available.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. Both men and women are welcome to join. You will need to have a confirmed diagnosis of folliculitis decalvans.

There might be other health conditions or medications that would prevent you from joining the study, as well as specific requirements related to your folliculitis decalvans that are needed. This is to make sure the study tests are safe and accurate for everyone involved.

Your study doctor will discuss all the specific criteria with you to see if this study is a good fit for your health and medical history.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with folliculitis decalvans?
Are you able to attend clinic visits for 12 months?
Are you willing to potentially receive one of the study's treatment medications?
Do you currently have symptoms of folliculitis decalvans that can be assessed?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive one of the study medications (Adalimumab, Ustekinumab, or Olumiant). You would have regular visits to the clinic over a period of 12 months. During these visits, a doctor or nurse, who won't know which specific treatment you're receiving (to ensure fair assessment), will check your scalp condition.

You'll also be asked to complete questionnaires about your pain, itching, and how the condition affects your daily life. These assessments will happen at the start, at 3 months, 6 months, and 12 months into the study. The total duration of your active participation in the study, receiving treatment and having assessments, would be one year.

Potential risks and benefits

Taking part in this study might offer you access to new treatments for folliculitis decalvans that are not yet widely available. There's a chance the treatment could improve your scalp condition, reduce pain and itching, and improve your quality of life. However, like all medicines, there can be potential side effects or risks, which your doctor will explain in detail. You might also not see any benefit from the study treatment. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is folliculitis decalvans?

It's a skin condition on the scalp that causes inflamed sores, pain, and can lead to permanent hair loss and scarring.

What kind of medicines are being tested?

Researchers are testing a few different medicines called 'biologics,' including Adalimumab, Ustekinumab, and Olumiant.

How long will the study last if I join?

If you participate, your involvement, including treatments and check-ups, would last for 12 months.

Will I know which treatment I'm getting?

It's an 'adaptive' trial, which means the specific treatment you get might be adjusted based on results. The main person assessing your condition won't know which drug you are on, to keep things fair.

What is the main goal of this study?

The main goal is to see if these new medicines can significantly reduce the severity of folliculitis decalvans after six months, making your scalp much better.