Back to resultsA Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clobetasol Propionate 0.05% Spray
Clobetasol Propionate 0.05% Foam
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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
Sites / Locations
- Solano Clinical Research
- Central Dermatology, PC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
clobetasol propionate (Clobex®) spray
clobetasol propionate (Olux®) foam
Outcomes
Primary Outcome Measures
Efficacy - Body Surface Area, Investigator Global Severity
Secondary Outcome Measures
Safety - Tolerability assessments, adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436540
Brief Title
A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Same as above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
clobetasol propionate (Clobex®) spray
Arm Title
2
Arm Type
Active Comparator
Arm Description
clobetasol propionate (Olux®) foam
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate 0.05% Spray
Other Intervention Name(s)
Clobex® Spray
Intervention Description
Apply to affected areas twice daily
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate 0.05% Foam
Other Intervention Name(s)
Olux® Foam
Intervention Description
Apply to affected areas twice daily
Primary Outcome Measure Information:
Title
Efficacy - Body Surface Area, Investigator Global Severity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety - Tolerability assessments, adverse events
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W. Gottschalk, MD
Organizational Affiliation
Galderma Laboratories, LP
Official's Role
Study Director
Facility Information:
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Central Dermatology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
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