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

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00436540
First received: February 16, 2007
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Clobetasol Propionate 0.05% Spray
Drug: Clobetasol Propionate 0.05% Foam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Efficacy - Body Surface Area, Investigator Global Severity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety - Tolerability assessments, adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: March 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
clobetasol propionate (Clobex®) spray
Drug: Clobetasol Propionate 0.05% Spray
Apply to affected areas twice daily
Other Name: Clobex® Spray
Active Comparator: 2
clobetasol propionate (Olux®) foam
Drug: Clobetasol Propionate 0.05% Foam
Apply to affected areas twice daily
Other Name: Olux® Foam

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436540

Locations
United States, California
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Missouri
Central Dermatology, PC
St. Louis, Missouri, United States, 63117
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W. Gottschalk, MD Galderma Laboratories, LP
  More Information

No publications provided

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00436540     History of Changes
Other Study ID Numbers: US10013
Study First Received: February 16, 2007
Last Updated: March 27, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014