Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
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ClinicalTrials.gov Identifier: NCT01020994 |
Recruitment Status
:
Completed
First Posted
: November 26, 2009
Last Update Posted
: July 9, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eczema | Drug: LAS41003 Drug: LAS189962 Drug: LAS189961 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: LAS41003 |
Drug: LAS41003
Once daily, topically
|
Active Comparator: LAS189962 |
Drug: LAS189962
Once daily, topically
|
Active Comparator: LAS189961 |
Drug: LAS189961
Once daily, topically
|
- Combination of clinical and microbial treatment success [ Time Frame: Day 14 ]
- Safety:Physical examination at EoT, AEs/SAEs during the entire study [ Time Frame: 2 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020994
Germany | |
Investigational Site | |
Bochum, Germany |
Study Director: | Christoph Willers, MD, MBA | Almirall Hermal GmbH |
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 |
First Posted: | November 26, 2009 Key Record Dates |
Last Update Posted: | July 9, 2010 |
Last Verified: | July 2010 |
Keywords provided by Almirall, S.A.:
Superficial infected eczema Superinfected eczema |
Additional relevant MeSH terms:
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous |