Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Condition: Inherited Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: Oleogel-S10; Mepilex® soft silicone faced polyurethane foam dressing
Intervention description: 1 cm or 125 µL or 115 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.; Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking description: Blinded comparison of wound photo series by two independent experts
Enrollment: 10.0
Sex: All
Minimum age: 1 Year
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Epidermolysis bullosa; Wound healing; Epithelialization

Summary:

      The purpose of this study was to compare intra-individually the reepithelialization of skin
      lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size
      divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and
      non-adhesive wound dressing versus non-adhesive wound dressing only.
    

Eligibility criteria:

        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

        Exclusion Criteria:

          1. Systemic treatment with steroids during the last 30 days

          2. Uncontrolled diabetes mellitus or diabetic ulcers

          3. Diseases or conditions that could, in the opinion of the investigator, interfere with
             the assessment of safety, tolerance or efficacy

          4. Skin disorders adversely affecting wound healing or involving the areas eligible for
             study treatment

          5. Hypersensitivity to the trial medication or surgical dressings to be used

          6. Multiple allergic disorders

          7. Administration of investigational drugs within 3 months before screening

          8. Investigations or changes in management for an existing medical condition

          9. Low probability to complete the study per protocol for whatever reason