A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam

Verified by: Galderma Laboratories, L.P., March 2008
First Received: February 16, 2007 | Last Updated: March 27, 2008 | Phase: Phase 4 | Start Date: March 2006
Overall Status: Completed | Estimated Enrollment: 78
  • …
  • Tell a FriendPrint

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...

Brief Summary

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

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

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/NCT00436540

Study ID Number: US10013

ClinicalTrials.gov Identifier: NCT00436540

Health Authority: United States: Institutional Review Board

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00436540