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”

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

Study Type: Interventional

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

Same as above.

Primary:

• Overall Disease Severity End of treatment (Week 4) No
• Tolerability assessments, incidence of adverse events Baseline, Weeks 1, 2, 4 and 8 Yes

Secondary:

• Overall Disease Severity Weeks 1, 2 and 8 No
• Investigator Global Assessment End of treatment (week 4) and Weeks 1, 2 and 8 No

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

Lead Sponsor: Galderma Laboratories, L.P.

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

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437255

Study ID Number: US10034

ClinicalTrials.gov Identifier: NCT00437255

Health Authority: United States: Institutional Review Board