Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

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

Total Enrollment

2488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-07-31

Brief Summary

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Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.

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Detailed Description

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Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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1

Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®

Clobetasol Propionate, 0.05%

Intervention Type DRUG

Apply twice daily for 2 or 4 weeks as monotherapy

2

Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment

Clobetasol propionate, 0.05% Spray

Intervention Type DRUG

Apply twice daily for 2 or 4 weeks as add-on therapy

Interventions

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Clobetasol Propionate, 0.05%

Apply twice daily for 2 or 4 weeks as monotherapy

Intervention Type DRUG

Clobetasol propionate, 0.05% Spray

Apply twice daily for 2 or 4 weeks as add-on therapy

Intervention Type DRUG

Other Intervention Names

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Clobex® Spray, 0.05% Clobex® Spray, 0.05%

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
* At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
* History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion Criteria

* Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
* Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
* Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No