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

Verified by: Galderma Laboratories, L.P., April 2008
First Received: February 16, 2007 | Last Updated: April 3, 2008 | Phase: Phase 4 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 122
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Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2007

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Galderma Laboratories, L.P. Industry

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, LP  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00437255