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

Study Primary Completion Date: June 2007

Same as above.

Intervention(s) in this Clinical Trial

• Drug: Clobetasol Propionate, 0.05%
  • Topical, twice daily for 4 weeks
• Drug: Calcipotriene and betamethasone dipropionate ointment
  • Topical, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Clobex® Spray
• Active Comparator: 2
  • Taclonex® Ointment

Primary Measures

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

Secondary Measures

• Overall Disease Severity
  • Time Frame: Weeks 1, 2 and 8
    Safety Issue?: No
• Investigator Global Assessment
  • Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Information obtained from ClinicalTrials.gov on July 02, 2009

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