Clinical trial NCT00354510: Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis
Official title: Randomised, Double-blind, Placebo-controlled Study of Topical GW842470X Formulation in Adults With Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Dermatitis, Atopic
Keywords: atopic dermatitis
GW842470X
PDE4 inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Safety and tolerability of 3% GW842470X cream
measure: Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
measure: Symptoms: pruritus & sleep loss
measure: Characterize systemic exposure to GW842470X following 21 days treatment.
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Mahlow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Duelmen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Schenefeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: