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Tests treatment safety and results for Hidradenitis Suppurativa
Official title Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
ClinicalTrials.gov ID: NCT05821478
What this study is testing
What is Lymecyclin and corresponding placebos of the experimental arm?
Lymecyclin and corresponding placebos of the experimental arm is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa.
Also referred to as Control treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- 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...
- Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and infra-mammary areafor women). Presence of nodules (inflamed or...
- Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year
You likely can't join if
- Pregnancy QT prolongation Abnormal result of routine lab tests corresponding to contra-indication to study treatments Unauthorized drug for the study...
- Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).
See the full eligibility 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...
- 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
- 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...
- 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 treatment 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
- 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...
- Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
- Paris, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France; Paris, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.