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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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ClinicalTrials.gov Identifier: NCT00356642
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: GW842470X Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2005
Actual Primary Completion Date : December 21, 2005
Actual Study Completion Date : December 21, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Single dose 1 cohort
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.
Drug: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.

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

Experimental: Repeat dose 1 cohort
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
Drug: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.

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

Experimental: Repeat dose 2 cohort
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
Drug: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.

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

Experimental: Repeat dose 3 cohort
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
Drug: GW842470X
GW842470X will be available as a yellow smooth water-in-oil cream.

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




Primary Outcome Measures :
  1. Number of subjects with abnormal physical examination findings [ Time Frame: Up to Day 22 ]
  2. Number of subjects with abnormal blood pressure [ Time Frame: Up to Day 22 ]
  3. Number of subjects with abnormal heart rate [ Time Frame: Up to Day 22 ]
  4. Number of subjects with abnormal 12-lead ECG assessment [ Time Frame: Up to Day 22 ]
  5. Number of subjects with abnormal findings on lead II cardiac monitoring [ Time Frame: Up to Day 10 ]
  6. Number of subjects with abnormal clinical laboratory tests [ Time Frame: Up to Day 22 ]
  7. 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 ]
  8. 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 Measures :
  1. 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 ]
  2. SCORAD [ Time Frame: Up to Day 10 ]
  3. BSA determination [ Time Frame: Up to Day 10 ]
  4. clinical photography [ Time Frame: Up to Day 10 ]
  5. measurement of barrier function using trans-epidermal water loss (TEWL) [ Time Frame: Up to Day 10 ]
  6. skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE) [ Time Frame: Up to Day 10 ]


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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356642


Locations
Germany
GSK Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356642     History of Changes
Other Study ID Numbers: TPD102031
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
PK
GW842470X
safety
tolerability
PD
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases