Doppelblinde, randomisierte, vehikelkontrollierte Wirksamkeits- und Sicherheitsstudie der Phase III mit 24-monatiger offener Nachbeobachtung zu Oleogel-S10 bei Patienten mit erblicher Epidermolysis bullosa

Drug: Oleogel-S10;Drug: Control gel

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 cm² to 50 cm²
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.