This is an open, prospective, controlled case-series documentation 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.
Conditions
Interventions
Product Name: Sericare
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: triterpene dry extract from birch cork
Current Sponsor code: TE
Concentration unit: % percent
Concentration type:
Sponsors
Birken GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged 1-95 years who have provided written informed consent. • EB Patients with skin lesions between 10 and 200 cm2. • prepared and comply with all trial requirements, including the following: o Application of Sericare on one half of the wound at every change of wound dressing; o Regular clinic visits during the treatment period, and follow-up period. • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Wound re-epithelialization of that part of the skin lesion, which is treated with Sericare (about 50%) compared to that part of the wound, which is covered by non-adhesive wound dressing alone;Secondary Objective: • Percentage of wound epithelialization • Touch sensitivity • Pruritus • Exudation • Assessment of efficacy (evaluated by both the investigators and patients or in case of infants one of their parents) • Assessment of tolerance (evaluated by both the investigators and patients or in case of infants one of their parents) ;Primary end point(s): The primary endpoint for the biometrical evaluation of the therapy is wound re-epithelialization of that part of the wound (about 50%), which is treated with Sericare compared to that part, which is covered by non-adhesive wound dressing alone. Alternatively comparison of 2 comparable wounds (size = 2 cm x 2,5 cm each) is allowed. A blinded assessment of the efficacy is conducted by two independent experts using a chronological series listing the macro-photographs per patient demonstrating for every timepoint, when wound dressings were changed, and a final examination at day 14 (for disease with recent wounds) or day 28 (for disease with delayed wound healing). | — |
Countries
Germany
Outcome results
None listed