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.
Information provided by (Responsible Party):
First received: July 25, 2006
Last updated: May 31, 2012
Last verified: February 2011
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).
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Physical examination
- Vital signs
- 12-lead ECG
- Lead II cardiac monitoring
- Clinical lab tests
Secondary Outcome Measures:
- Time to max concentration and terminal half-life
- BSA determination
- clinical photography
- measurement of barrier function using trans-epidermal water loss (TEWL)
- skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
| Estimated Enrollment:
| Study Start Date:
Other Name: GW842470X
|Ages Eligible for Study:
||18 Years to 67 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|GSK Investigational Site
|Berlin, Germany, 10117 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 25, 2006
||May 31, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2015
Genetic Diseases, Inborn
Immune System Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic