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

Last updated: January 11, 2024
Sponsor: Institut Pasteur
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rosacea

Scalp Disorders

Hidradenitis Suppurativa

Treatment

Lymecyclin and corresponding placebos of the experimental arm

ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy

Clinical Study ID

NCT05821478
2018-018
  • Ages 18-59
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 theinverse regions of the body, presenting with nodules, sinus-tracts and/orscarring.
  • Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (andinfra-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
  • Clinical severity of HS at inclusion: Hurley stage 2
  • BMI < 35
  • Written informed consent from patient
  • Patient able to complete DLQI
  • Patients affiliated to the French health system (Assurance Maladie), except Frenchstate medical aid beneficiaries (Aide Médicale d'Etat)
  • Active compatible contraception for men and women of childbearing or inability toprocreate
  • Available laboratory blood test performed within the last 2-months Non inclusion Criteria:
  • 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/kidneydysfunction, porphyria, mandatory use of nonsteroidal anti-inflammatory drugs (NSAIDs) forother medical conditions
  • Unbalanced diabetes (ie HbA1c above 7%)
  • Dysphagia, untreated gastro-oesophageal reflux/ulcer
  • BMI ≥ 35
  • Immune suppression, inflammatory disease, including gastroenterologic andrheumatologic 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, mightinterfere with the evaluation of the study objectives (e.g patient unable to completeDLQI, 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 chronicdisease other than HS
  • Alcohol-dependant patients defined as an addiction to alcohol with a negative impacton health, social or personal life

Exclusion

Exclusion criteria: Pregnancy QT prolongation Abnormal result of routine lab tests corresponding tocontra-indication to study treatments Unauthorized drug for the study during all the study (from study treatments interactions listed in the SmPC, Cf. unauthorized drug listed innon-inclusion criteria). Development of hypersensitivity to any of the study products and/or excipients (e.g.lactose, corn starch, riboflavin).

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Lymecyclin and corresponding placebos of the experimental arm
Phase: 3
Study Start date:
April 15, 2024
Estimated Completion Date:
September 15, 2026

Study Description

The antibiotic strategy is targeted against specific pathobionts which have been identified in HS lesions by the investigator's team.

Half of participants will receive a 3-week course of ceftriaxone + metronidazole treatment followed by 3 weeks of rifampicin + moxifloxacin + metronidazole combination, then 6 weeks of rifampin + moxifloxacin (experimental groupe), versus a 12 weeks course of lymecycline (control group) Double blind treatment phase will stop at week 12. All patients whatever their randomization arm or their remission status will begin follow-up treatment according to standard care recommendations (Société Française de Dermatologie): lymecycline, doxycycline or cotrimoxazole. Prescription will be upon decision of the investigator.

This maintenance treatment is not experimental.

Connect with a study center

  • Hôpital Edouard Herriot

    Lyon,
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille,
    France

    Site Not Available

  • Centre Médical de l'Institut Pasteur

    Paris,
    France

    Site Not Available

  • Hopital St Joseph

    Paris,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

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