Phase
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
Ages 18-59 All Genders
Study Summary
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
Study Description
Connect with a study center
Hôpital Edouard Herriot
Lyon,
FranceSite Not Available
Hôpital de la Timone
Marseille,
FranceSite Not Available
Centre Médical de l'Institut Pasteur
Paris,
FranceSite Not Available
Hopital St Joseph
Paris,
FranceSite Not Available
CHU de Rouen
Rouen,
FranceSite Not Available
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