Safety and Tolerability of topically applied Bovine Lung Surfactant on intact skin and Superficial subepidermal lesions in Healthy Volunteers
Phase 1
- Conditions
- MeSH C17 Skin and Connective Tissue DiseasesMedDRA - Epidermal and dermal conditions (10014982)MedDRA - Skin and subcutaneous tissue disorders (10040785)healty subjects
- Registration Number
- DRKS00011353
- Lead Sponsor
- niversität Bremen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Two healthy forearms, no known chronical skin diseases, dermatoses or allergies, Signed form of consent, Caucasian
Exclusion Criteria
Pregnancy or nursing period, Diabetes (Type I or II), systemic or infectious diseases, skin disease, Known allergies against bovine products or wound dressings, Mental diseases, missing ability to consent, Addictive disorders (e.g. alcohol, drugs), Peripheral circulatory disorder, Morbus Raynaud, Current (or < 4 weeks ago) participation in clinical trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability of Lung Surfactant in cutanous application measured by Clinical Scoring Scale for dermatitis(CSS), nine times (8 times every two days and one time follow up after 30 days)
- Secondary Outcome Measures
Name Time Method Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface, pain measured by Visual Analogue Scale, TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure <br>nine times (8 times every two days and one time follow up after 30 days)<br><br>