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

Primary Purpose

Eczema

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LAS41003
LAS189962
LAS189961
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema focused on measuring Superficial infected eczema, Superinfected eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

LAS41003

LAS189962

LAS189961

Arm Description

Outcomes

Primary Outcome Measures

Combination of clinical and microbial treatment success

Secondary Outcome Measures

Safety:Physical examination at EoT, AEs/SAEs during the entire study

Full Information

First Posted
November 24, 2009
Last Updated
July 8, 2010
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01020994
Brief Title
Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Almirall, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Superficial infected eczema, Superinfected eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LAS41003
Arm Type
Experimental
Arm Title
LAS189962
Arm Type
Active Comparator
Arm Title
LAS189961
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LAS41003
Intervention Description
Once daily, topically
Intervention Type
Drug
Intervention Name(s)
LAS189962
Intervention Description
Once daily, topically
Intervention Type
Drug
Intervention Name(s)
LAS189961
Intervention Description
Once daily, topically
Primary Outcome Measure Information:
Title
Combination of clinical and microbial treatment success
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Safety:Physical examination at EoT, AEs/SAEs during the entire study
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Willers, MD, MBA
Organizational Affiliation
Almirall Hermal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Bochum
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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