Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-04-30

Brief Summary

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This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

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Detailed Description

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Same as above.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clobetasol propionate spray

clobetasol propionate spray 0.05%

Group Type ACTIVE_COMPARATOR

clobetasol propionate spray

Intervention Type DRUG

Apply twice daily

clobetasol propionate ointment

clobetasol propionate ointment 0.05%

Group Type ACTIVE_COMPARATOR

clobetasol propionate ointment

Intervention Type DRUG

Apply twice daily

Interventions

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clobetasol propionate spray

Apply twice daily

Intervention Type DRUG

clobetasol propionate ointment

Apply twice daily

Intervention Type DRUG

Other Intervention Names

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Clobex® Spray

Eligibility Criteria

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Inclusion Criteria

* Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
* Overall disease severity is at least 3 (moderate)

Exclusion Criteria

* Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
* Subjects whose psoriasis involves only the scalp, face or groin
* Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No