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Table 2 Inclusion and exclusion criteria

From: Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale

Inclusion criteria Exclusion criteria
Male and female patients with JEB, DEB, or Kindler syndrome aged ≥ 4 years (children aged < 4 years may be included only after confirmation by the Independent Data Monitoring Committee upon review of the safety and bioanalytical data at the interim safety review stage)
Patients with an EB target wound (i.e. EB partial thickness wound of 10–50 cm2 in size aged ≥ 21 days and < 9 months) with no signs of local infection
Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed consent form, and has/have given written informed consent
Patient and/or his/her legal representative must be able and willing to follow study procedures and instructions
Patients with EBS
EB target wound with clinical signs of local infection
Use of systemic antibiotics for wound-related infections within 7 days before enrollment
Administration of systemic or topical steroids (except for inhaled, ophthalmic, or topical applications, such as budesonide suspension for esophageal strictures [e.g. Pulmicort Respules® 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrollment
Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before enrollment
Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB
Current and/or former malignancy including basal cell carcinomas and squamous cell carcinomas
Enrollment in any interventional study or treated with any investigational drug for any disease within 4 weeks before study entry
Factors present in the patient and/or his/her legal representative that could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes
Pregnant or nursing women
Women of childbearing potential including post-menarchal female adolescents and men who are not willing to use an effective form of birth control with failure rates < 1% per year (e.g. implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomy, or vasectomized partner) during participation in the study (and at least 3 months thereafter)
Patient is a member of the investigational team or his/her immediate family
Patient lives in the same household as a study participant
  1. EB epidermolysis bullosa, DEB dystrophic EB, EBS EB simplex, JEB junctional EB