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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Birken AG

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