Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema

This study has been completed.
Sponsor:
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01020994
First received: November 24, 2009
Last updated: July 8, 2010
Last verified: July 2010

November 24, 2009
July 8, 2010
November 2009
June 2010   (final data collection date for primary outcome measure)
Combination of clinical and microbial treatment success [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01020994 on ClinicalTrials.gov Archive Site
Safety:Physical examination at EoT, AEs/SAEs during the entire study [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eczema
  • Drug: LAS41003
    Once daily, topically
  • Drug: LAS189962
    Once daily, topically
  • Drug: LAS189961
    Once daily, topically
  • Experimental: LAS41003
    Intervention: Drug: LAS41003
  • Active Comparator: LAS189962
    Intervention: Drug: LAS189962
  • Active Comparator: LAS189961
    Intervention: Drug: LAS189961
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01020994
H 552 000 - 0911, EudraCT: 2009-011931-11
No
Head of Global Clinical Development, Almirall Hermal GmbH
Almirall, S.A.
Not Provided
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
Almirall, S.A.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP