Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis

This study has been completed.

First Received: July 25, 2006 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00356642

Purpose

The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis.

GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).

Condition	Intervention	Phase
Atopic Dermatitis	Drug: GW842470X	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Safety Study, Single Blind, Single Group Assignment, Treatment
Official Title:	A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Physical examination
Vital signs
12-lead ECG
Cmax
Clinical lab tests
AUC
Lead II cardiac monitoring

Secondary Outcome Measures:

Time to max concentration and terminal half-life
SCORAD
BSA determination
skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
measurement of barrier function using trans-epidermal water loss (TEWL)
clinical photography

Estimated Enrollment:	42
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
BMI range 18.5-29.9m2 at least 2 index lesions and BSA involvement >10%.
14 day washout of current therapy.

Exclusion criteria:

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 or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone.
Patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356642

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TPD102031
Study First Received:	July 25, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00356642 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Atopic Dermatitis
GW842470X
PD

PK
safety
tolerability

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:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

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

ClinicalTrials.gov processed this record on March 16, 2009