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Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
This study has been completed.
Sponsor:
Almirall, S.A.
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01020994
First received: November 24, 2009
Last updated: July 8, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Eczema | Drug: LAS41003 Drug: LAS189962 Drug: LAS189961 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
atopic dermatitis
MedlinePlus related topics:
Eczema
U.S. FDA Resources
Further study details as provided by Almirall, S.A.:
Primary Outcome Measures:
- Combination of clinical and microbial treatment success [ Time Frame: Day 14 ]
Secondary Outcome Measures:
- Safety:Physical examination at EoT, AEs/SAEs during the entire study [ Time Frame: 2 weeks ]
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LAS41003 |
Drug: LAS41003
Once daily, topically
|
| Active Comparator: LAS189962 |
Drug: LAS189962
Once daily, topically
|
| Active Comparator: LAS189961 |
Drug: LAS189961
Once daily, topically
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020994
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020994
Locations
| Germany | |
| Investigational Site | |
| Bochum, Germany | |
Sponsors and Collaborators
Almirall, S.A.
Investigators
| Study Director: | Christoph Willers, MD, MBA | Almirall Hermal GmbH |
More Information
| Responsible Party: | Head of Global Clinical Development, Almirall Hermal GmbH |
| ClinicalTrials.gov Identifier: | NCT01020994 History of Changes |
| Other Study ID Numbers: |
H 552 000 - 0911 EudraCT: 2009-011931-11 |
| Study First Received: | November 24, 2009 |
| Last Updated: | July 8, 2010 |
Keywords provided by Almirall, S.A.:
|
Superficial infected eczema Superinfected eczema |
Additional relevant MeSH terms:
|
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous |
ClinicalTrials.gov processed this record on June 23, 2017