search
Back to results

Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

Primary Purpose

Atopic Dermatitis, Dermatitis, Atopic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW842470X cream
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, GW842470X, PDE4 inhibitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
July 18, 2006
Last Updated
May 31, 2012
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00354510
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Dermatitis, Atopic
Keywords
atopic dermatitis, GW842470X, PDE4 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
190 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW842470X cream
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety and tolerability of 3% GW842470X cream
Title
Clinical efficacy using SCORing Atopic Dermatitis score & Investigators Global Assessment Scale
Title
Symptoms: pruritus & sleep loss
Title
Characterize systemic exposure to GW842470X following 21 days treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Facility Name
GSK Investigational Site
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Facility Name
GSK Investigational Site
City
Duelmen
State/Province
Niedersachsen
ZIP/Postal Code
48249
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51063
Country
Germany
Facility Name
GSK Investigational Site
City
Schenefeld
State/Province
Schleswig-Holstein
ZIP/Postal Code
22869
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6531 LB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CJ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

We'll reach out to this number within 24 hrs