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

Launched by INSTITUT PASTEUR · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of antibiotic treatment for patients with Hurley stage 2 Hidradenitis Suppurativa (HS), a painful skin condition that causes bumps and abscesses in certain areas of the body. The study will compare this new treatment to a commonly used antibiotic, tetracycline. It aims to find out which treatment works better for reducing flare-ups and improving symptoms in patients who have experienced multiple episodes of HS over the past year.

To be eligible for the trial, participants must be adults under 60 years old with a confirmed diagnosis of HS that has been active for at least a year, with at least four flare-ups in the previous year. They should also have a body mass index (BMI) under 35 and be able to provide consent to participate. Throughout the trial, participants will receive regular check-ups, and their responses to the treatments will be monitored to see how well they are doing. It's important to note that this study is not yet recruiting, so interested individuals will need to wait until it officially starts.

Gender

ALL

Eligibility criteria

• 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).