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

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

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'

Secondary Outcome

 Percentage of Wound Epithelialization at Day 7±1

Condition

Inherited Epidermolysis Bullosa

Intervention

Oleogel-S10

Study Arms / Comparison Groups

 Oleogel-S10

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'.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

November 2010

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility 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
      

Gender

All

Ages

1 Year - 95 Years

Accepts Healthy Volunteers

No

Contacts

Agnes Schwieger-Briel, MD, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT01294241

Organization ID

BEB-10

Responsible Party

Sponsor

Study Sponsor

Birken AG

Study Sponsor

Agnes Schwieger-Briel, MD, Principal Investigator, University Medical Center Freiburg

Verification Date

May 2017