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

NCT ID: NCT00356642

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-10

Study Completion Date

2005-12-21

Brief Summary

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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).

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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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.

Group Type EXPERIMENTAL

GW842470X

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

GW842470X

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

GW842470X

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

GW842470X

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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GW842470X

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

References

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Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015 Jan 23;10:185-92. doi: 10.2147/COPD.S74557. eCollection 2015.

Reference Type DERIVED
PMID: 25670894 (View on PubMed)

Other Identifiers

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TPD102031

Identifier Type: -

Identifier Source: org_study_id