Eczema
Conditions
Keywords
Superficial infected eczema, Superinfected eczema
Brief summary
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.
Interventions
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of clinical and microbial treatment success | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Safety:Physical examination at EoT, AEs/SAEs during the entire study | 2 weeks |
Countries
Germany
Outcome results
None listed