Back to resultsStudy Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GW842470X
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring PK, GW842470X, safety, tolerability, PD, Atopic Dermatitis
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Single dose 1 cohort
Repeat dose 1 cohort
Repeat dose 2 cohort
Repeat dose 3 cohort
Arm Description
Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1.
Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1
Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1
Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1
Outcomes
Primary Outcome Measures
Number of subjects with abnormal physical examination findings
Number of subjects with abnormal blood pressure
Number of subjects with abnormal heart rate
Number of subjects with abnormal 12-lead ECG assessment
Number of subjects with abnormal findings on lead II cardiac monitoring
Number of subjects with abnormal clinical laboratory 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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356642
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2005 (Actual)
Primary Completion Date
December 21, 2005 (Actual)
Study Completion Date
December 21, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
PK, GW842470X, safety, tolerability, PD, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose 1 cohort
Arm Type
Experimental
Arm Description
Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1.
Arm Title
Repeat dose 1 cohort
Arm Type
Experimental
Arm Description
Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1
Arm Title
Repeat dose 2 cohort
Arm Type
Experimental
Arm Description
Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1
Arm Title
Repeat dose 3 cohort
Arm Type
Experimental
Arm Description
Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1
Intervention Type
Drug
Intervention Name(s)
GW842470X
Intervention Description
GW842470X will be available as a yellow smooth water-in-oil cream.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Primary Outcome Measure Information:
Title
Number of subjects with abnormal physical examination findings
Time Frame
Up to Day 22
Title
Number of subjects with abnormal blood pressure
Time Frame
Up to Day 22
Title
Number of subjects with abnormal heart rate
Time Frame
Up to Day 22
Title
Number of subjects with abnormal 12-lead ECG assessment
Time Frame
Up to Day 22
Title
Number of subjects with abnormal findings on lead II cardiac monitoring
Time Frame
Up to Day 10
Title
Number of subjects with abnormal clinical laboratory tests
Time Frame
Up to Day 22
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
SCORAD
Time Frame
Up to Day 10
Title
BSA determination
Time Frame
Up to Day 10
Title
clinical photography
Time Frame
Up to Day 10
Title
measurement of barrier function using trans-epidermal water loss (TEWL)
Time Frame
Up to Day 10
Title
skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
Time Frame
Up to Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25670894
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.
Results Reference
derived
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Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
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