Back to resultsOleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Primary Purpose
Inherited Epidermolysis Bullosa
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Oleogel-S10
Mepilex® soft silicone faced polyurethane foam dressing
Sponsored by
About this trial
This is an interventional treatment trial for Inherited Epidermolysis Bullosa focused on measuring Epidermolysis bullosa, Wound healing, Epithelialization
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
Sites / Locations
- EB Center at the Department of Dermatology, University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Oleogel-S10
Non-adhesive wound dressing
Arm Description
The eligible wound (half) was topically treated with Oleogel-S10 and covered with a non-adhesive wound dressing (Mepilex®) on Day 0. Wound dressings were 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'.
Mepilex® soft silicone faced polyurethane foam dressing was used as non-active comparator. The eligible wound (half) was covered with Mepilex® as control on Day 0. Wound dressings were 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'.
Outcomes
Primary Outcome Measures
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'
The primary end point was the progress of reepithelialization from baseline to either Day 14 ('recent wounds') or Day 28 ('chronic wounds') of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other ('winner'), or whether there was no difference in reepithelialization.
Secondary Outcome Measures
Percentage of Wound Epithelialization at Day 7±1
The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Percentage of Wound Epithelialization at Day 14±1
The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294241
Brief Title
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Official Title
Open, Prospective, Controlled Case Series Documentation to Compare Intra-individually the Efficacy and Tolerance of Sericare® Versus Non-adhesive Wound Dressing Alone in Accelerating the Epithelialization of Skin Lesions of Patients With Epidermolysis Bullosa Hereditaria
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birken AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
This study was designed as an open-label, prospective, controlled, blindly evaluated, monocentric phase II case series documentation in patients with inherited Epidermolysis bullosa (EB). The investigator either identified 1 EB wound ≥10 cm2 and ≤200 cm2 in size and divided it into 2 halves or selected 2 comparable wounds of ≥5 cm2 each. One (half of the) EB wound was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control. Wound dressings were 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'. This was an open-label study. The investigator, the participant, and the sponsor knew the identity of the treatment. Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inherited Epidermolysis Bullosa
Keywords
Epidermolysis bullosa, Wound healing, Epithelialization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Blinded comparison of wound photo series by two independent experts
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oleogel-S10
Arm Type
Experimental
Arm Description
The eligible wound (half) was topically treated with Oleogel-S10 and covered with a non-adhesive wound dressing (Mepilex®) on Day 0. Wound dressings were 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'.
Arm Title
Non-adhesive wound dressing
Arm Type
Other
Arm Description
Mepilex® soft silicone faced polyurethane foam dressing was used as non-active comparator. The eligible wound (half) was covered with Mepilex® as control on Day 0. Wound dressings were 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'.
Intervention Type
Drug
Intervention Name(s)
Oleogel-S10
Other Intervention Name(s)
Sericare®
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'.
Intervention Type
Device
Intervention Name(s)
Mepilex® soft silicone faced polyurethane foam dressing
Other Intervention Name(s)
Cutaneous patch
Intervention Description
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'.
Primary Outcome Measure Information:
Title
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'
Description
The primary end point was the progress of reepithelialization from baseline to either Day 14 ('recent wounds') or Day 28 ('chronic wounds') of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other ('winner'), or whether there was no difference in reepithelialization.
Time Frame
14 days for 'recent wounds', 28 days for 'chronic wounds'
Secondary Outcome Measure Information:
Title
Percentage of Wound Epithelialization at Day 7±1
Description
The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Time Frame
Day 7±1
Title
Percentage of Wound Epithelialization at Day 14±1
Description
The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.
Time Frame
Day 14±1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Schwieger-Briel, MD
Organizational Affiliation
University Medical Center Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
EB Center at the Department of Dermatology, University Medical Center
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
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