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Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

NCT ID: NCT00842153

Last Updated: 2017-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-01-31

Brief Summary

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The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.

Detailed Description

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The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.

Conditions

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Psoriasis

Keywords

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Psoriasis Plaque Type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Clobetasol Propionate Foam

Topical foam formulation that includes clobetasol propionate (Steroid)

Group Type EXPERIMENTAL

Clobetasol propionate foam

Intervention Type DRUG

Topical Clobetasol propionate foam

Vehicle Foam

Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.

Group Type PLACEBO_COMPARATOR

Vehicle foam

Intervention Type DRUG

Vehicle foam does not include the active drug.

Interventions

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Clobetasol propionate foam

Topical Clobetasol propionate foam

Intervention Type DRUG

Vehicle foam

Vehicle foam does not include the active drug.

Intervention Type DRUG

Other Intervention Names

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Olux-E

Eligibility Criteria

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Inclusion Criteria

* Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
* Mild to moderate, plaque-type psoriasis
* Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
* Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria

* Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
* Subjects who have not complied with the proper wash-out periods for prohibited medications
* Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
* Skin disease/disorder that might interfere with the study related diagnosis or evaluations
* Evidence of recent alcohol or drug abuse
* History of poor cooperation, non-compliance with medical treatment or unreliability
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Stiefel, a GSK Company

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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Center for Dermatology, Cosmetic and Laser

Fremont, California, United States

Site Status

Dermatology Specialists

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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OEF0701

Identifier Type: -

Identifier Source: org_study_id