Actively Recruiting

Phase 3
Age: 18Years - 59Years
All Genders
NCT05821478

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

Led by Institut Pasteur · Updated on 2025-07-09

92

Participants Needed

4

Research Sites

144 weeks

Total Duration

On this page

Sponsors

I

Institut Pasteur

Lead Sponsor

C

Centre Hospitalier Universitaire de Caen

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults under 60 years old
  • Diagnosis of Hidradenitis Suppurativa according to European Dermatology guidelines
  • Recurrent inflammation more than twice in the past 6 months in inverse body regions with nodules, sinus tracts, or scarring
  • Involvement of axilla, genitofemoral area, perineum, gluteal area, or inframammary area in women
  • Presence of nodules, sinus tracts, abscesses, or scarring
  • Active HS with at least 1 year duration and 4 or more flares in the previous year
  • Clinical severity at Hurley stage 2
  • Body mass index (BMI) less than 35
  • Written informed consent
  • Ability to complete Dermatology Life Quality Index (DLQI)
  • Affiliated with the French health system (except French state medical aid beneficiaries)
  • Use of active contraception or inability to procreate for men and women of childbearing potential
  • Available laboratory blood test within the last 2 months
Not Eligible

You will not qualify if you...

  • Age under 18 or 60 years and older
  • Hurley stage 3 HS
  • Previous use of the experimental treatment
  • Use of unauthorized drugs for the study within the month before inclusion
  • Contraindications to study treatments or excipients such as pregnancy, breastfeeding, allergies to study drugs, wheat allergy, tendinopathy, QT prolongation, bradycardia, heart failure, heart rhythm disturbances, electrolyte disorders, hypokalemia, coagulation disorders, severe liver or kidney dysfunction, porphyria, or required use of NSAIDs for other conditions
  • Uncontrolled diabetes (HbA1c above 7%)
  • Dysphagia or untreated gastroesophageal reflux or ulcer
  • Body mass index (BMI) of 35 or higher
  • Immune suppression or inflammatory diseases including gastroenterologic and rheumatologic conditions
  • Lactase deficiency, lactose or galactose intolerance
  • Malabsorption syndrome
  • Living in the same household as another patient
  • Under guardianship or curatorship
  • Any condition interfering with study evaluation or poor expected adherence
  • Participation in another interventional health product research
  • Need for repeated antibiotic use (more than 3 times per year) for other chronic diseases than HS
  • Alcohol dependence
  • Pregnancy, QT prolongation, abnormal lab tests contraindicating study treatments
  • Development of hypersensitivity to study products or excipients during the study
  • Use of unauthorized drugs during the study according to drug interaction guidelines

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Hôpital de la Timone

Marseille, France

Not Yet Recruiting

2

Centre Médical de l'Institut Pasteur

Paris, France

Actively Recruiting

3

Hopital St Joseph

Paris, France

Active, Not Recruiting

4

CHU de Rouen

Rouen, France

Not Yet Recruiting

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Research Team

M

Maïa Delage-Toriel, MD

CONTACT

A

Aude Nassif, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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