Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Study of Topical GW842470X Formulation in Adults With Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354510
• Other study ID #: TPD103280
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: May 31, 2012
• Start date: March 2006

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• GW842470X cream

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Duelmen	Niedersachsen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mahlow	Brandenburg
Germany	GSK Investigational Site	Schenefeld	Schleswig-Holstein
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

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