RecruitingPhase 3NCT05821478

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

A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients Versus Tetracycline Derivative


Sponsor

Institut Pasteur

Enrollment

92 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 59 Years

Inclusion Criteria30

  • Adults < 60 years old
  • Diagnosis of HS according to European Dermatology guidelines:
  • Recurrent inflammation occurring more than 2 times in the past 6 months in the inverse regions of the body, presenting with nodules, sinus-tracts and/or scarring.
  • Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and infra-mammary areafor women). Presence of nodules (inflamed or noninflamed), sinus tracts (inflamed or noninflamed), abscesses, scarring (atrophic, mesh-like, red, hypertrophic or linear)
  • Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year
  • BMI < 35
  • Written informed consent from patient
  • Patient able to complete DLQI
  • Patients affiliated to the French health system (Assurance Maladie), except French state medical aid beneficiaries (Aide Médicale d'Etat)
  • Active compatible contraception for men and women of childbearing or inability to procreate
  • Available laboratory blood test performed within the last 2-months
  • Person < 18 and ≥ 60 years old
  • Former stage 3 HS
  • Previous use of the experimental treatment
  • Unauthorized drugs for the study during the month preceding the inclusion
  • Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably):
  • pregnancy, breastfeeding, known allergy to experimental or reference drugs, wheat allergy, tendinopathy, QT prolongation, bradycardia, heart failure, heart rhythm disturbances, hydroelectrolytic disorders, hypokalemia, coagulation disorders, severe liver/kidney dysfunction, porphyria, mandatory use of nonsteroidal anti-inflammatory drugs (NSAIDs) for other medical conditions
  • Unbalanced diabetes (ie HbA1c above 7%)
  • Dysphagia, untreated gastro-oesophageal reflux/ulcer
  • BMI ≥ 35
  • Immune suppression, inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions
  • Lactase deficiency, lactose and galactose intolerance
  • Malabsorption syndrome
  • Person living in the same household as another patient
  • Person under guardianship or curatorship
  • Individuals with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g patient unable to complete DLQI, or poor predictable observance
  • Participation in another interventional research on health products studies
  • Patients requiring repeated (more than 3/year) use of antibiotics for a chronic disease other than HS
  • Alcohol-dependant patients defined as an addiction to alcohol with a negative impact on health, social or personal life
  • Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).

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Interventions

DRUGROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy

a 3-week course of ceftriaxone injection + oral metronidazole followed by a 3-week course of oral rifampicin + moxifloxacin +metronidazole followed by a 6-week course of oral rifampicin + moxifloxacin

DRUGLymecyclin and corresponding placebos of the experimental arm

12-week course of oral lymecycline.


Locations(4)

Hôpital de la Timone

Marseille, France

Centre Médical de l'Institut Pasteur

Paris, France

Hopital St Joseph

Paris, France

CHU de Rouen

Rouen, France

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NCT05821478


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