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

Study Identifier:
BEB-10
ClinicalTrials.gov Identifier:
NCT01294241
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Dermatology
Study Drug
  • Drug: Oleogel-S10
Date
Nov 2010 - Jun 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 1 Year - 95 Years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
EB Center at the Department of Dermatology, University Medical Center
Freiburg, Germany, 79104
Status
N/A