Eczema Clinical Trial
Official title:
Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema
Verified date | July 2010 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinically diagnosed super-infected or impetiginized eczema Exclusion Criteria: - Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment - Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication - Diagnose of the following disease: - Known active tuberculosis or any history of past tuberculosis of skin - Suspected or proven parasitic infection of the treatment site (e.g. scabies) - Psoriasis - Suspected or proven viral infection of skin (e.g. Herpes) - Localization of the superficial infected eczema: - Palms of the hands - Sole of a foot - Face - Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Investigational Site | Bochum |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combination of clinical and microbial treatment success | Day 14 | No | |
Secondary | Safety:Physical examination at EoT, AEs/SAEs during the entire study | 2 weeks | Yes |
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