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

NCT01294241 | Completed Phase 2 Results

• 1 other identifier: BEB-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Inherited Epidermolysis Bullosa

Keywords

Epidermolysis bullosa; Wound healing; Epithelialization

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days for 'recent wounds', 28 days for 'chronic wounds'

Secondary Outcomes (2)

• Percentage of Wound Epithelialization at Day 7±1

  Day 7±1

• Percentage of Wound Epithelialization at Day 14±1

  Day 14±1

Study Arms (2)

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'.

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'.

Device: Mepilex® soft silicone faced polyurethane foam dressing

Interventions

Oleogel-S10 DRUG

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'.

Also known as: Sericare®

Oleogel-S10

Mepilex® soft silicone faced polyurethane foam dressing DEVICE

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'.

Also known as: Cutaneous patch

Non-adhesive wound dressing; Oleogel-S10

Eligibility Criteria

• Age: 1 Year - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birken AG: lead

Study Sites (1)

EB Center at the Department of Dermatology, University Medical Center

Freiburg im Breisgau, 79104, Germany

Location

MeSH Terms

Conditions

Epidermolysis Bullosa

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

Small sample size, subjects with dystrophic Epidermolysis bullosa only, difficult wound size analysis at fixed study days due to several episodes of re-trauma in both intervention and control wounds

Results Point of Contact

• Title: Head of Clinical Development
• Organization: Amryt Pharma

medinfo@amrytpharma.com

+353 1 669 4606

Study Officials

• Agnes Schwieger-Briel, MD

  University Medical Center Freiburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded comparison of wound photo series by two independent experts
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: February 11, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)