Inherited Epidermolysis BullosaPhase 2NCT01294241
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
A Phase 2 study testing Oleogel-S10 and Mepilex® soft silicone faced polyurethane foam dressing in people with Inherited Epidermolysis Bullosa, run by Birken AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 95 years
- Conditions the study is for
- Inherited Epidermolysis Bullosa
- What is being tested?
- Oleogel-S10 and Mepilex® soft silicone faced polyurethane foam dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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')
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
EB Center at the Department of Dermatology, University Medical Center
Freiburg im Breisgau, 79104
About this study
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
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.
Read the 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.
- Conditions
- Inherited Epidermolysis Bullosa
- Being tested
- Oleogel-S10, Mepilex® soft silicone faced polyurethane foam dressing
- Keywords
- Epidermolysis bullosa, Wound healing, Epithelialization
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10Drug
Also called Sericare®
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 dressingDevice
Also called Cutaneous patch
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'.
| Study group | Role | What they receive |
|---|---|---|
| Oleogel-S10 | Experimental | 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'. Receives: Drug: Oleogel-S10; Device: Mepilex® soft silicone faced polyurethane foam dressing |
| Non-adhesive wound dressing | Other | 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'. Receives: Device: Mepilex® soft silicone faced polyurethane foam dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days for 'recent wounds', 28 days for 'chronic wounds'
Secondary outcomes (2)
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.
Measured: Day 7±1
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.
Measured: Day 14±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inherited Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birken AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnes Schwieger-Briel, MD, Principal investigator, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294241
- Sponsor's protocol ID
- BEB-10
- Status last verified
- May 2017
- First submitted
- 27 Oct 2010
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01294241
- Acronym / sponsor ID
- BEB-10
- Conditions
- Inherited Epidermolysis Bullosa
- Keywords
- Epidermolysis bullosa, Wound healing, Epithelialization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Birken AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oleogel-S10 | Experimental | Drug: Oleogel-S10, Device: Mepilex® soft silicone faced polyurethane foam dressingThe 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'. |
| Non-adhesive wound dressing | Other | Device: Mepilex® soft silicone faced polyurethane foam dressingMepilex® 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'. |
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Negative pregnancy test in women of childbearing potential within 7 days before start of treatment
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleogel-S10Also: Sericare®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'. | Drug | Oleogel-S10 |
| Mepilex® soft silicone faced polyurethane foam dressingAlso: Cutaneous patchMepilex® 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'. | Device | Non-adhesive wound dressing, Oleogel-S10 |
Primary outcome
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'
Time frame: 14 days for 'recent wounds', 28 days for '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.
2 secondary outcomes
Percentage of Wound Epithelialization at Day 7±1
Time frame: Day 7±1
Percentage of Wound Epithelialization at Day 14±1
Time frame: Day 14±1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Schwieger-Briel, MD principal investigator
University Medical Center Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oleogel-S10 and Mepilex® soft silicone faced polyurethane foam dressing in people with Inherited Epidermolysis Bullosa, run by Birken AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds' (time frame: 14 days for 'recent wounds', 28 days for 'chronic wounds'). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.