Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00354510

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: GW842470X cream	Phase II

MedlinePlus related topics: Eczema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised, Double-Blind, Placebo-Controlled Study of Topical GW842470X Formulation in Adults With Moderate Atopic Dermatitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).

Secondary Outcome Measures:

Safety and tolerability of 3% GW842470X cream
Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
Symptoms: pruritus & sleep loss
Characterize systemic exposure to GW842470X following 21 days treatment.

Estimated Enrollment:	190
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354510

Locations

Germany
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 22143
GSK Investigational Site
Hamburg, Germany, 20249
Germany, Bayern
GSK Investigational Site
Augsburg, Bayern, Germany, 86179
Germany, Brandenburg
GSK Investigational Site
Mahlow, Brandenburg, Germany, 15831
Germany, Niedersachsen
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Germany, Nordrhein-Westfalen
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51063
Germany, Schleswig-Holstein
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
UTRECHT, Netherlands, 3584 CJ
GSK Investigational Site
NIJMEGEN, Netherlands, 6531 LB

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TPD103280
Study First Received:	July 18, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00354510
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

GW842470X
PDE4 inhibitor
atopic dermatitis

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009