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Clinical Trials in France / NCT05821478
Recruiting Phase 3

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

NCT05821478 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-05-22
Last updated
2025-07-09

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapyLymecyclin and corresponding placebos of the experimental arm

ROCEPHIN, 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

Lymecyclin and corresponding placebos of the experimental arm: 12-week course of oral lymecycline.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
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 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 * 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 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 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/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 Exclusion criteria: Pregnancy QT prolongation Abnormal result of routine lab tests corresponding to contra-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 in non-inclusion criteria). Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Hôpital de la Timone Marseille France Not Yet Recruiting
Centre Médical de l'Institut Pasteur Paris France Recruiting
Hopital St Joseph Paris France Active Not Recruiting
CHU de Rouen Rouen France Not Yet Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05821478 on ClinicalTrials.gov ↗ ← All trials in France