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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Clobetasol Propionate, 0.05% (Drug); Clobetasol propionate, 0.05% Spray (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, LP

Summary

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.

Clinical Details

Official title: Phase 4 Open-Label Multicenter Community-Based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis

Study design: Observational Model: Case-Only

Primary outcome: Efficacy - Change in Target Plaque Severity rating

Secondary outcome:

Efficacy - Self-Assessment of Quality of Life, Subject satisfaction

Safety - Evaluation of adverse events and tolerability

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

DHC Dimensional HealthCare, Inc. (Clinical Research Organization), Cedar Knolls, New Jersey 76117, United States
Additional Information

Starting date: February 2006
Last updated: March 27, 2008

Page last updated: August 23, 2015

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