Last updated: 11/04/2018 12:52:18

Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis

GSK study ID
TPD102031
See study documents
Clinicaltrials.gov ID
NCT00356642
EudraCT ID
2005-000274-48
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Number of subjects with abnormal physical examination findings

Timeframe: Up to Day 22

Number of subjects with abnormal blood pressure

Timeframe: Up to Day 22

Number of subjects with abnormal heart rate

Timeframe: Up to Day 22

Number of subjects with abnormal 12-lead ECG assessment

Timeframe: Up to Day 22

Number of subjects with abnormal findings on lead II cardiac monitoring

Timeframe: Up to Day 10

Number of subjects with abnormal clinical laboratory tests

Timeframe: Up to Day 22

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

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:

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

SCORAD

Timeframe: Up to Day 10

BSA determination

Timeframe: Up to Day 10

clinical photography

Timeframe: Up to Day 10

measurement of barrier function using trans-epidermal water loss (TEWL)

Timeframe: Up to Day 10

skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)

Timeframe: Up to Day 10

Interventions:
Drug: GW842470X
Drug: Placebo
Enrollment:
45
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dermatitis, Atopic
Product
GW842470
Collaborators
Not applicable
Study date(s)
June 2005 to December 2005
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 67 years
Accepts healthy volunteers
No
  • Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
  • BMI range 18.5-29.9m2
  • 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.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10117
Status
Terminated/Withdrawn
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-21-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 102031 can be found on the GSK Clinical Study Register.
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