Trial record 17 of 37 for:    "epidermolysis bullosa simplex" OR "Epidermolysis Bullosa"

Case Series Documentation of Patients With Epidermolysis Bullosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birken AG
ClinicalTrials.gov Identifier:
NCT01294241
First received: October 27, 2010
Last updated: July 29, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare intra-individually the efficacy and tolerance of Sericare® versus standard treatment in accelerating the epithelialization of skin lesions of patients with Epidermolysis bullosa hereditaria.


Condition Intervention Phase
Epidermolysis Bullosa Hereditaria
Drug: Sericare®
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Birken AG:

Primary Outcome Measures:
  • Evaluation which part of the skin lesion showed a better re-epithelization - the part of the wound treated with Sericare® and non-adhesive wound dressing vs. the part of the wound covered by non-adhesive wound dressing alone [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of wound epithelialization [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]
    Assessment is performed by the investigator at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)

  • Touch sensitivity [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]
    Assessment is performed at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)

  • Pruritus [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]
    Assessment is performed at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)

  • Exudation [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]
    Assessment is performed at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)

  • Assessment of efficacy [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: No ]
    Assessment is performed by the investigator at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)

  • Assessment of tolerance [ Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing ] [ Designated as safety issue: Yes ]
    Assessment is performed by the investigator at every wound dressing change for both wound parts (treated with Sericare® and non-adhesive wound dressing vs non-adhesive wound dressing alone)


Enrollment: 10
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sericare®
    • Sericare® on one half of the skin lesion (each time when the wound dressing is changed, normally every 24-48 hours)
    • Non-adhesive wound dressings alone on the other half of the skin lesion
    Other Name: Oleogel-S10
Detailed Description:

The design of the trial is a case-series documentation of each individual patient involved in the trial, and an assessment of the treatment for each patient without the need for comparison and statistical analysis of different groups of patients. A comparison of the Sericare® treated Epidermolysis Bullosa (EB) wounds with the untreated part of the same wound will enable independent experts to assess the outcome of the treatment. Objective methods will be applied to evaluate the wound healing progress, i.e., the grade of epithelialization of the wound.

  Eligibility

Ages Eligible for Study:   1 Year to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 1-95 years who have provided written informed consent. In case of minor patients, written informed consent of parents or legal representatives is available.
  • EB Patients with at least one skin lesion between 10 and 200 cm2.
  • prepared and comply with all trial requirements, including the following:

    • Application of Sericare on one half of the wound at every change of wound dressing;
    • Regular clinic visits during the treatment period and follow-up period (14 days for disease with recent wounds or 28 days for disease with delayed wound healing after the start of the treatment).
  • Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
  • Women of childbearing potential must agree 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 must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.

Exclusion Criteria:

  • received treatment with systemic steroids during the last 30 days;
  • uncontrolled diabetes or diabetic ulcers;
  • diseases or conditions that could, in the opinion of the investigator, interfere with the assessment of safety, tolerance or efficacy;
  • a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the recent wounds or involves the areas to be examined in this case-series documentation;
  • a history of clinically significant hypersensitivity to the trial medication or surgical dressings to be used in this case-series documentation;
  • known multiple allergic disorders;
  • taking, or have taken, any investigational drugs within 3 months prior to the screening visit;
  • undergoing investigations or changes in management for an existing medical condition;
  • not likely to complete the case-series documentation for whatever reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294241

Locations
Germany
Universitäts-Hautklinik Freiburg
Freiburg, Germany, 79104
Sponsors and Collaborators
Birken AG
Investigators
Principal Investigator: Agnes Schwieger-Briel, Dr. Universitäts-Hautklinik Freiburg
  More Information

No publications provided

Responsible Party: Birken AG
ClinicalTrials.gov Identifier: NCT01294241     History of Changes
Other Study ID Numbers: BEB-10
Study First Received: October 27, 2010
Last Updated: July 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Birken AG:
Epidermolysis bullosa
Wound healing
Epithelialization

Additional relevant MeSH terms:
Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on August 28, 2014