Phase 2
N=10
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Inherited Epidermolysis Bullosa
Bottom Line
View on ClinicalTrials.gov: NCT01294241 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds' — 8; 0 Wounds — p==0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oleogel-S10 (Drug); Mepilex® soft silicone faced polyurethane foam dressing (Device)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Birken AG
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds' |
8; 0 | =0.008 sig |
| SECONDARY Percentage of Wound Epithelialization at Day 7±1 |
69.7; 57.4 | =0.21 |
| SECONDARY Percentage of Wound Epithelialization at Day 14±1 |
87.7; 79.2 | 0.33 |
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
- Patients aged 1-95 years
- Patient and/or his/her legal representative was informed, read and understood the patient information/informed consent form and gave written informed consent
- 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)
- Patient and/or his/her legal representative was able and willing to follow study procedures and instructions including the following:
- Application of Oleogel-S10 on (1 half of) the wound at every wound dressing change
- Regular visits during the treatment period (14 days in 'recent wounds' to 28 days in 'chronic wounds')
- Negative pregnancy test in women of childbearing potential within 7 days before start of treatment
- 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
- Men of procreative capacity agreed to use an effective method of contraception during treatment and for at least 6 months thereafter
Exclusion Criteria
- Systemic treatment with steroids during the last 30 days
- Uncontrolled diabetes mellitus or diabetic ulcers
- Diseases or conditions that could, in the opinion of the investigator, interfere with the assessment of safety, tolerance or efficacy
- Skin disorders adversely affecting wound healing or involving the areas eligible for study treatment
- Hypersensitivity to the trial medication or surgical dressings to be used
- Multiple allergic disorders
- Administration of investigational drugs within 3 months before screening
- Investigations or changes in management for an existing medical condition
- Low probability to complete the study per protocol for whatever reason
Data sourced from ClinicalTrials.gov (NCT01294241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.