Last updated on May 2020

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Epidermolysis Bullosa
  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male and female patients with the following subtypes of inherited EB: junctional EB (JEB), dystrophic EB (DEB), and Kindler syndrome aged 21 days,
  • Patients with an EB target wound (i.e., EB partial thickness wound of 10 cm to 50 cm in size aged 21 days and <9 months),
  • 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.

Exclusion Criteria:

  • Patient has EB simplex
  • EB target wound with clinical signs of local infection,
  • Use of systemic antibiotics for wound-related infections within 7 days prior to enrolment,
  • Administration of systemic or topical steroids (except for inhaled, ophthalmic or topical applications, such as budesonide suspension for oesophageal strictures [e.g., Pulmicort respules 0.25 mg/2 mL or 0.5 mg/2 mL]) within 30 days before enrolment,
  • Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment,
  • 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,
  • Enrolment in any interventional study or treated with any investigational drug for any disease within 4 weeks prior to 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 and women of childbearing potential including postmenarchal female adolescents 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, vasectomised 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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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