Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354510

Enrollment

190

Registered

2006-07-20

Start date

2006-03-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Dermatitis, Atopic

Keywords

atopic dermatitis, GW842470X, PDE4 inhibitor

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.

Interventions

DRUGGW842470X cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026