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Completed

NCT Number: NCT00356642

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

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).

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW842470X

Drug

GW842470X will be available as a yellow smooth water-in-oil cream.

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jul 26, 2006
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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