Dermatitis, Atopic
Conditions
Keywords
PK, GW842470X, safety, tolerability, PD, Atopic Dermatitis
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).
Interventions
DRUGGW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.
DRUGPlacebo
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of subjects with abnormal blood pressure | Up to Day 22 |
| Number of subjects with abnormal heart rate | Up to Day 22 |
| Number of subjects with abnormal 12-lead ECG assessment | Up to Day 22 |
| Number of subjects with abnormal findings on lead II cardiac monitoring | Up to Day 10 |
| Number of subjects with abnormal clinical laboratory tests | Up to Day 22 |
| 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 |
| Number of subjects with abnormal physical examination findings | Up to Day 22 |
Secondary
| Measure | Time frame |
|---|---|
| SCORAD | Up to Day 10 |
| BSA determination | Up to Day 10 |
| clinical photography | Up to Day 10 |
| measurement of barrier function using trans-epidermal water loss (TEWL) | Up to Day 10 |
| skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE) | Up to Day 10 |
| 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 |
Countries
Germany
Outcome results
None listed