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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436540
First Posted: February 19, 2007
Last Update Posted: March 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Galderma Laboratories, L.P.
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • Safety - Tolerability assessments, adverse events [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00436540     History of Changes
Other Study ID Numbers: US10013
First Submitted: February 16, 2007
First Posted: February 19, 2007
Last Update Posted: March 31, 2008
Last Verified: March 2008

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