Official Title: “A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis”

The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.

Study Type: Interventional

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

Study Primary Completion Date: January 2007

Same as above.

Intervention(s) in this Clinical Trial

• Drug: Clobetasol Propionate 0.05% Spray
  • Apply to affected areas twice daily
• Drug: Clobetasol Propionate 0.05% Foam
  • Apply to affected areas twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • clobetasol propionate (Clobex®) spray
• Active Comparator: 2
  • clobetasol propionate (Olux®) foam

Primary Measures

• Efficacy - Body Surface Area, Investigator Global Severity
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Safety - Tolerability assessments, adverse events
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved

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 50 grams per week of Olux® foam
• Subjects whose psoriasis involves the scalp, face or groin
• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00436540

Study ID Number: US10013

ClinicalTrials.gov Identifier: NCT00436540

Health Authority: United States: Institutional Review Board