RecruitingPHASE3INTERVENTIONAL

Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients

This research trial is for adults with moderate hidradenitis suppurativa (HS), a long-term skin condition causing painful lumps and abscesses. The study aims to test if new combinations of antibiotics, given over several weeks, are more effective at treating HS than the usual antibiotic, lymecycline. We know certain bacteria play a role in HS, and this study tries to target those specific bacteria with different antibiotic mixes. Participants will receive either a new antibiotic combination or lymecycline, and doctors will carefully monitor their condition. The goal is to find better ways to manage HS symptoms and improve people's quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Institut Pasteur

Enrolment target

Start

22 May 2025

Estimated completion

27 Feb 2028

Hidradenitis Suppurativa

What is this study about?

This research study is about finding better treatments for a skin condition called hidradenitis suppurativa, often shortened to HS. If you have HS, you might experience painful lumps, boils, or tunnels under your skin, particularly in areas like your armpits, groin, or under the breasts. This study focuses on people with 'moderate' HS (called Hurley Stage 2), meaning the condition is noticeable and active but not yet at its most severe.

The main idea behind this study is to see if a new way of using antibiotics can help people with HS more effectively. Doctors involved in this research have identified certain types of bacteria that seem to be particularly important in HS lesions. They've designed an 'adapted' antibiotic treatment that aims to target these specific bacteria. This new treatment combines different antibiotics given in stages, hoping to tackle the problem more comprehensively than a single antibiotic might.

Half of the people in the study will get this new, multi-stage antibiotic treatment. The other half will receive a standard antibiotic called lymecycline, which is often used for HS. By comparing these two approaches, the researchers hope to understand if the new antibiotic combinations are better at reducing HS symptoms. All treatments are given as part of a carefully monitored clinical trial to ensure safety and effectiveness.

Key takeaways

This study aims to find better antibiotic treatments for moderate HS.
It compares a new combination of antibiotics to a standard antibiotic (lymecycline).
Participation involves 12 weeks of study treatment, plus ongoing standard care.
The study is 'double-blind', so neither you nor your doctor will know which treatment you receive initially.
You must be an adult (18-59) with moderate HS and meet other health criteria to join.

Who may be eligible?

To join this study, you need to be an adult between 18 and 59 years old. You must have hidradenitis suppurativa (HS) that meets specific criteria, including having had it for at least a year with regular flare-ups, and having 'moderate' HS (doctors call this Hurley Stage 2). Your Body Mass Index (BMI) also needs to be under 35. You'll also need to be part of the French health system and use effective birth control if you could become pregnant or make someone pregnant.

There are certain reasons why you wouldn't be able to join. For example, if you're under 18 or 60 or older, or if your HS is very severe (Hurley Stage 3). You also can't have been on the new experimental treatment before. People with certain health conditions, such as uncontrolled diabetes, severe liver or kidney problems, or particular allergies to the study medications (including during pregnancy or breastfeeding), cannot take part. If you have certain heart conditions or are taking specific medications that would interfere with the study drugs, you'd also be excluded.

Basically, the study needs people with a clear diagnosis of moderate HS who are otherwise generally healthy enough to safely take the study medications. This helps make sure the results are reliable and that participants are not put at unnecessary risk.

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 between 18 and 59 years old?
Do you have a diagnosis of moderate HS (Hurley Stage 2)?
Have you had HS for at least a year, with regular flare-ups?
Are you able to use reliable birth control if you could become pregnant or make someone pregnant?
Do you have any serious allergies or health conditions that might prevent you from taking antibiotics?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to give your informed consent, meaning you understand what's involved and agree to participate. You'll then be randomly assigned to one of two groups. One group will receive the new, multi-stage antibiotic treatment, which involves different antibiotics given over 12 weeks. The other group will receive lymecycline daily for 12 weeks.

During these 12 weeks, you'll have regular visits to the clinic so doctors can monitor your health and how your HS is reacting to the treatment. This will involve physical examinations and possibly blood tests. After the 12-week treatment phase, everyone in the study will switch to a standard follow-up treatment for HS, like lymecycline, doxycycline, or cotrimoxazole, as decided by your doctor. This is considered standard care and is not part of the experimental treatment being tested. The total duration of your active participation (treatment phase) will be 12 weeks, with ongoing follow-up care as usual.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new and potentially more effective treatment for your HS, or receiving standard care under close medical supervision. This could lead to an improvement in your HS symptoms. However, as with any medication, there are potential risks, such as side effects from the antibiotics used. Your study doctor will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Hôpital de la Timone
Verified postcode
Marseille, France· Not yet recruiting
Centre Médical de l'Institut Pasteur
Verified postcode
Paris, France· Recruiting
Hopital St Joseph
Verified postcode
Paris, France· Active not recruiting
CHU de Rouen
Verified postcode
Rouen, France· Not yet recruiting

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps, boils, and sometimes tunnels under the skin, usually in areas where skin rubs together, like armpits and groin.

What kind of treatment will I get?

You'll either receive a new combination of antibiotics given in stages over 12 weeks, or a standard antibiotic called lymecycline daily for 12 weeks.

Will I know which treatment I'm receiving?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are on during the first 12 weeks. This helps make the study fair.

How long will I be in the study treatment phase?

The active treatment phase where you receive either the experimental antibiotics or lymecycline will last for 12 weeks.

What happens after the 12 weeks?

After 12 weeks, all participants will switch to a standard antibiotic treatment for HS, such as lymecycline, doxycycline, or cotrimoxazole, as prescribed by your doctor. This is not part of the experimental study.

How to find out more

Maïa Delage-Toriel, MD

maia.delage-toriel@pasteur.fr +33 1 40 61 30 77 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.