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Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354510
First received: July 18, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Dermatitis, Atopic
 Drug: GW842470X cream
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Study of Topical GW842470X Formulation in Adults With Moderate Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 190
Study Start Date: March 2006
Intervention Details:
    Drug: GW842470X cream
    Other Name: GW842470X cream
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354510

Locations
Germany
GSK Investigational Site
Augsburg, Bayern, Germany, 86179
GSK Investigational Site
Mahlow, Brandenburg, Germany, 15831
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51063
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 20249
GSK Investigational Site
Hamburg, Germany, 22143
Netherlands
GSK Investigational Site
Nijmegen, Netherlands, 6531 LB
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00354510     History of Changes
Other Study ID Numbers: TPD103280
Study First Received: July 18, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
atopic dermatitis
GW842470X
PDE4 inhibitor

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013