Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356642
First received: July 25, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).


Condition Intervention Phase
Atopic Dermatitis
Dermatitis, Atopic
Drug: GW842470X
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Physical examination
  • Vital signs
  • 12-lead ECG
  • Lead II cardiac monitoring
  • Clinical lab tests
  • AUC
  • Cmax

Secondary Outcome Measures:
  • Time to max concentration and terminal half-life
  • SCORAD
  • BSA determination
  • clinical photography
  • measurement of barrier function using trans-epidermal water loss (TEWL)
  • skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)

Estimated Enrollment: 42
Study Start Date: June 2005
Intervention Details:
    Drug: GW842470X
    Other Name: GW842470X
  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
  • BMI range 18.5-29.9m2 at least 2 index lesions and BSA involvement >10%.
  • 14 day washout of current therapy.

Exclusion criteria:

  • 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 or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone.
  • Patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356642

Locations
Germany
GSK Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356642     History of Changes
Other Study ID Numbers: TPD102031
Study First Received: July 25, 2006
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
PK
GW842470X
safety
tolerability
PD
Atopic Dermatitis

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

ClinicalTrials.gov processed this record on September 22, 2014