A Randomised, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Efficacy of Recombinant Human B[beta] Defensin 2 (rHuB[beta]D2 cream) in the Treatment of Staphylococcus aureus and other Infections in the Skin of Patients with Atopic Dermatitis
Phase 1
Completed
- Conditions
- Atopic DermatitisSkin - Dermatological conditions
- Registration Number
- ACTRN12610000438055
- Lead Sponsor
- Planton GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Currently suffering from atopic dermatitis (AD) with a primary diagnosis of AD at least 12 weeks prior to inclusion into the study.
With a SCORAD between 20 and 50 (i.e., mild to moderate AD).
Diagnosed with disseminated symmetric dermatitis.
Colonisation of lesional skin with Staphylococcus aureus (and probably other micro-organisms)
Exclusion Criteria
Current use of the following therapeutic interventions at the affected areas of the skin and a zone of 4 cm around the affected areas:
- Any kind of topical glucocorticosteroidproducts
- Cyclosporine or other calcineurin inhibitors
- Topical antibiotics or antiseptics (also in ointments)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method