A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

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Detailed Description

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This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.

Conditions

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Plaque-Type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Olux-E Foam

Olux-E (clobetasol propionate 0.05%) foam

Group Type EXPERIMENTAL

Olux-E Foam

Intervention Type DRUG

Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.

Clobex lotion

Clobex (clobetasol propionate 0.05%) lotion.

Group Type ACTIVE_COMPARATOR

Clobex lotion

Intervention Type DRUG

Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15

Interventions

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Olux-E Foam

Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.

Intervention Type DRUG

Clobex lotion

Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15

Intervention Type DRUG

Other Intervention Names

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clobetasol lotion Clobex

Eligibility Criteria

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Inclusion Criteria

* Body surface area (BSA) affected with psoriasis between 4% and 20% .
* Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
* Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
* Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
* Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
* Male or female, 18 years of age or older at the time that the consent form was signed.
* Able to complete the study and comply with study instructions.
* Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

Exclusion Criteria

* Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
* Other serious skin disorder or any chronic medical condition that is not well controlled.
* Female subjects who are pregnant, trying to become pregnant or lactating.
* Any major illness within 30 days prior to the baseline visit.
* Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No