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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01294241
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE February 11, 2011
Results First Submitted Date  ICMJE October 22, 2016
Results First Posted Date  ICMJE January 23, 2018
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • Evaluation which part of the skin lesion for disease with recent wounds showed a better re-epithelization - the part of the wound treated with Sericare or the part of the wound covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • Evaluation which part of the skin lesion for disease with delayed wound healing showed a better re-epithelization - the part of the wound treated with Sericare or the part of the wound covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2017)
  • Percentage of Wound Epithelialization at Day 7±1 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • •Percentage of wound epithelialization for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Touch sensitivity for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Pruritus for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Exudation for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Assessment of efficacy for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Assessment of tolerance for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 14 days after start of treatment ]
    Assessment is performed whenever the change of the wound dressing is indicated and a final examination 14 days after start of treatment for disease with recent wounds
  • •Percentage of wound epithelialization for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
  • •Touch sensitivity for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
  • •Pruritus for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
  • •Exudation for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
  • •Assessment of efficacy for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
  • •Assessment of tolerance for disease with recent wounds comparing the part of the wound that is treated with Sericare and the part of the wound, that is covered by non-adhesive wound dressing alone [ Time Frame: 28 days after start of treatment ]
    Assessment is performed regarding wounds whenever the change of the wound dressing is indicated and a final examination 28 days after start of treatment for disease with delayed wound healing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Blinded comparison of wound photo series by two independent experts
Primary Purpose: Treatment
Condition  ICMJE Inherited Epidermolysis Bullosa
Intervention  ICMJE
  • Drug: Oleogel-S10
    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'.
    Other Name: Sericare®
  • Device: Mepilex® soft silicone faced polyurethane foam dressing
    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'.
    Other Name: Cutaneous patch
Study Arms  ICMJE
  • Experimental: Oleogel-S10
    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'.
    Interventions:
    • Drug: Oleogel-S10
    • Device: Mepilex® soft silicone faced polyurethane foam dressing
  • Non-adhesive wound dressing
    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: Device: Mepilex® soft silicone faced polyurethane foam dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 95 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01294241
Other Study ID Numbers  ICMJE BEB-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amryt Pharma ( Birken AG )
Study Sponsor  ICMJE Birken AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnes Schwieger-Briel, MD University Medical Center Freiburg
PRS Account Amryt Pharma
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP