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

GlaxoSmithKline45 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Dermatitis, Atopic

Interventions

GW842470XDRUG

GW842470X will be available as a yellow smooth water-in-oil cream.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 67 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Berlin, Germany

Outcomes

Primary Outcomes

Number of subjects with abnormal physical examination findings

Time frame: Up to Day 22

Number of subjects with abnormal blood pressure

Time frame: Up to Day 22

Number of subjects with abnormal heart rate

Time frame: Up to Day 22

Number of subjects with abnormal 12-lead ECG assessment

Time frame: Up to Day 22

Number of subjects with abnormal findings on lead II cardiac monitoring

Time frame: Up to Day 10

Number of subjects with abnormal clinical laboratory tests

Time frame: Up to Day 22

AUC

Time frame: 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

Cmax

Time frame: 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 Outcomes

Time to max concentration and terminal half-life

Time frame: 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

SCORAD

Time frame: Up to Day 10

BSA determination

Data from ClinicalTrials.gov

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