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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

July 18, 2006
May 31, 2012
March 2006
Not Provided
Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI).
Clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI.
Complete list of historical versions of study NCT00354510 on ClinicalTrials.gov Archive Site
  • 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.
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.
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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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Atopic Dermatitis
  • Dermatitis, Atopic
Drug: GW842470X cream
Other Name: GW842470X cream
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT00354510
TPD103280
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP