Clinical trial NCT00356642: Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Keywords: PK
GW842470X
safety
tolerability
PD
Atopic Dermatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Number of subjects with abnormal physical examination findings
timeFrame: Up to Day 22
measure: Number of subjects with abnormal blood pressure
timeFrame: Up to Day 22
measure: Number of subjects with abnormal heart rate
timeFrame: Up to Day 22
measure: Number of subjects with abnormal 12-lead ECG assessment
timeFrame: Up to Day 22
measure: Number of subjects with abnormal findings on lead II cardiac monitoring
timeFrame: Up to Day 10
measure: Number of subjects with abnormal clinical laboratory tests
timeFrame: Up to Day 22
measure: AUC
timeFrame: 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
measure: Cmax
timeFrame: 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:
measure: Time to max concentration and terminal half-life
timeFrame: 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
measure: SCORAD
timeFrame: Up to Day 10
measure: BSA determination
timeFrame: Up to Day 10
measure: clinical photography
timeFrame: Up to Day 10
measure: measurement of barrier function using trans-epidermal water loss (TEWL)
timeFrame: Up to Day 10
measure: skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015 Jan 23;10:185-92. doi: 10.2147/COPD.S74557. eCollection 2015.