Back to resultsEfficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clobetasol Propionate, 0.05%
Calcipotriene and betamethasone dipropionate ointment
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
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
Sites / Locations
- Minnesota Clinical Study Center
- DermResearch, Inc.
- J & S Studies, Inc.
- Baylor Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Clobex® Spray
Taclonex® Ointment
Outcomes
Primary Outcome Measures
Overall Disease Severity
Tolerability assessments, incidence of adverse events
Secondary Outcome Measures
Overall Disease Severity
Investigator Global Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437255
Brief Title
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
Detailed Description
Same as above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Clobex® Spray
Arm Title
2
Arm Type
Active Comparator
Arm Description
Taclonex® Ointment
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate, 0.05%
Other Intervention Name(s)
Clobex® Spray
Intervention Description
Topical, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Calcipotriene and betamethasone dipropionate ointment
Other Intervention Name(s)
Taclonex® Ointment
Intervention Description
Topical, once daily
Primary Outcome Measure Information:
Title
Overall Disease Severity
Time Frame
End of treatment (Week 4)
Title
Tolerability assessments, incidence of adverse events
Time Frame
Baseline, Weeks 1, 2, 4 and 8
Secondary Outcome Measure Information:
Title
Overall Disease Severity
Time Frame
Weeks 1, 2 and 8
Title
Investigator Global Assessment
Time Frame
End of treatment (week 4) and Weeks 1, 2 and 8
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:
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
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
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
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