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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356642
• Other study ID #: TPD102031
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: September 27, 2017
• Start date: June 10, 2005
• Est. completion date: December 21, 2005

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 21, 2005
• Est. primary completion date: December 21, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
• Placebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with abnormal physical examination findings		Up to Day 22
Primary	Number of subjects with abnormal blood pressure		Up to Day 22
Primary	Number of subjects with abnormal heart rate		Up to Day 22
Primary	Number of subjects with abnormal 12-lead ECG assessment		Up to Day 22
Primary	Number of subjects with abnormal findings on lead II cardiac monitoring		Up to Day 10
Primary	Number of subjects with abnormal clinical laboratory tests		Up to Day 22
Primary	AUC		Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Primary	Cmax		Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Secondary	Time to max concentration and terminal half-life		Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Secondary	SCORAD		Up to Day 10
Secondary	BSA determination		Up to Day 10
Secondary	clinical photography		Up to Day 10
Secondary	measurement of barrier function using trans-epidermal water loss (TEWL)		Up to Day 10
Secondary	skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)		Up to Day 10

External Links

•   Results for study 102031 can be found on the GSK Clinical Study Register.