Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
Status and phase
Completed
Phase 1
Conditions
Dermatitis, Atopic
Treatments
Drug: GW842470X
Drug: Placebo
Details and patient eligibility
About
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).
Enrollment
45 patients
Sex
All
Ages
18 to 67 years old
Volunteers
No Healthy Volunteers
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.
Trial design
45 participants in 4 patient groups
Single dose 1 cohort
Experimental group
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.
Treatment:
Drug: GW842470X
Drug: Placebo
Repeat dose 1 cohort
Experimental group
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
Treatment:
Drug: GW842470X
Drug: Placebo
Repeat dose 2 cohort
Experimental group
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
Treatment:
Drug: GW842470X
Drug: Placebo
Repeat dose 3 cohort
Experimental group
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
Treatment:
Drug: GW842470X
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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