Official Title: “A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis”

The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Same as above.

Intervention(s) in this Clinical Trial

• Drug: clobetasol propionate spray 0.05%
  • clobetasol propionate spray, 0.05%, applied topically twice daily
• Drug: calcitriol ointment
  • calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Primary Measures

• Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score
  • Time Frame: 8 weeks
    Safety Issue?: No
• Efficacy - Overall Disease Severity, Global Improvement Score, Signs of Psoriasis, Percent change from baseline in Body Surface Area
  • Time Frame: 2, 4, 8 and 12 weeks
    Safety Issue?: No
• Efficacy - Koo-Menter Psoriasis Qualify of Life Questionnaire; Subject Satisfaction Survey
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety - Tolerability, adverse events
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
• Overall Disease Severity of at least 3 (moderate)

Exclusion Criteria:

• Surface area involvement too large (>20% BSA)
• Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

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, L.P.  

Overall Contact: Luz E Colon, MS 817-961-5243 lucy.colon@galderma.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00658788

Study ID Number: US10085

ClinicalTrials.gov Identifier: NCT00658788

Health Authority: United States: Food and Drug Administration