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

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

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.

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: Case-Only, Other

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.

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

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

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