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)
Percentage of patients reaching clinical remission at week 12, defined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1)) — at week 12 The clinical remission is defined as a 90% improvement of the International Hidradenitis Suppurativa Severity Score (IHS4) at week 12 compared to the baseline.
The IHS4 score is a validated composite score developped to assess dynamically HS severity (1). It is calculated by adding the number of inflammatory nodules to the number of abscesses multiplied by 2 and to the number of draining tunnels multiplied by 4. A total score of 3 or less corresponds to mild severity HS, 4-10 to moderate severity HS and 11 or higher to severe disease.
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.
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