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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LAS41003

Group Type EXPERIMENTAL

LAS41003

Intervention Type DRUG

Once daily, topically

LAS189962

Group Type ACTIVE_COMPARATOR

LAS189962

Intervention Type DRUG

Once daily, topically

LAS189961

Group Type ACTIVE_COMPARATOR

LAS189961

Intervention Type DRUG

Once daily, topically

Interventions

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LAS41003

Once daily, topically

Intervention Type DRUG

LAS189962

Once daily, topically

Intervention Type DRUG

LAS189961

Once daily, topically

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No