Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

Inclusion Criteria

• •1. Patients aged 1-95 years
• •2. Patient and/or his/her legal representative was informed, read and understood the patient information/informed consent form and gave written informed consent
• •3. Patients with inherited EB with at least 1 skin lesion between 10 cm2 and 200 cm2 (alternatively 2 comparable lesions of at least 5 cm2 each)
• •4. Patient and/or his/her legal representative was able and willing to follow study procedures and instructions including the following:
• •1. Application of Oleogel-S10 on (1 half of) the wound at every wound dressing change
• •2. Regular visits during the treatment period (14 days in 'recent wounds' to 28 days in 'chronic wounds')
• •5. Negative pregnancy test in women of childbearing potential within 7 days before start of treatment
• •6. Women of childbearing potential agreed to use an effective method of contraception (Pearl Index \< 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter
• •7. Men of procreative capacity agreed to use an effective method of contraception during treatment and for at least 6 months thereafter