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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
Sponsor:
Information provided by:
Almirall, S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eczema Drug: LAS41003 Drug: LAS189962 Drug: LAS189961 Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Combination of clinical and microbial treatment success [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Safety:Physical examination at EoT, AEs/SAEs during the entire study [ Time Frame: 2 weeks ]

Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Germany
Investigational Site
Bochum, Germany
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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