Case Series Documentation of Patients With Epidermolysis Bullosa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01294241
• Date of registration: 27/10/2010
• Prospective Registration: No
• Primary sponsor: Birken AG
• Public title: Case Series Documentation of Patients With Epidermolysis Bullosa
• Scientific 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
• Date of first enrolment: October 2010
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01294241
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Agnes Schwieger-Briel, Dr.
• Affiliation: Universitäts-Hautklinik Freiburg

Key inclusion & exclusion 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.



Age minimum: 1 Year
Age maximum: 95 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Epidermolysis Bullosa Hereditaria

Intervention(s)

Drug: Sericare®

Primary Outcome(s)

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]

Secondary Outcome(s)

Touch sensitivity [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Pruritus [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Assessment of efficacy [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Percentage of wound epithelialization [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Assessment of tolerance [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Exudation [Time Frame: 14 days for recent wounds / 28 days for wounds with delayed healing]

Secondary ID(s)

BEB-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors