Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

NCT ID: NCT00354510

Last Updated: 2012-06-04

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

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI) assessment of disease severity and to investigate the safety of and tolerability of 3% GW842470X cream on diseased skin of adult patients.

Detailed Description

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Conditions

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Atopic Dermatitis Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW842470X cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate atopic dermatitis patients (IGA=3).
* The disease involvement must be \>5% of body surface area.
* Female patients of child-bearing potential must use an appropriate method of contraception.

Exclusion Criteria

* Patients with any active skin disease other than atopic dermatitis will not be eligible.
* Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 10 days prior to first application and/or oral anti-histamines within 5 days of the first dose.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Augsburg, Bavaria, Germany

Site Status

GSK Investigational Site

Mahlow, Brandenburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Duelmen, Lower Saxony, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Nijmegen, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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TPD103280

Identifier Type: -

Identifier Source: org_study_id

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