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Hidradenitis Suppurativa

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

Sponsored by Institut Pasteur

About this trial

Last updated 2 years ago

Study ID

2018-018

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 59 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

Locations

Location

Status