Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

Condition(s) targeted: Plaque Psoriasis

Intervention: Clobetasol Propionate, 0.05% (Drug); Calcipotriene and betamethasone dipropionate ointment (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

Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.

Official title: An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Overall Disease Severity

Tolerability assessments, incidence of adverse events

Secondary outcome:

Overall Disease Severity

Investigator Global Assessment

Detailed description: Same as above.

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

Criteria:

Inclusion Criteria:

- Moderate to severe psoriasis involving 3-20% of the body surface area

Exclusion Criteria:

- Subjects who have surface area involvement too large that would require more than 50

grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment

- Subjects having psoriasis that involves the scalp, face, or groin

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

DermResearch, Inc., Austin, Texas 78759, United States

J & S Studies, Inc., Bryan, Texas 77802, United States

Baylor Research Institute, Dallas, Texas 75230, United States

Starting date: August 2006
Ending date: June 2007
Last updated: April 3, 2008