Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
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ClinicalTrials.gov Identifier: NCT00658788 |
Recruitment Status :
Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
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Sponsor:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
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Tracking Information | ||||
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First Submitted Date ICMJE | March 4, 2008 | |||
First Posted Date ICMJE | April 15, 2008 | |||
Results First Submitted Date ICMJE | August 12, 2014 | |||
Results First Posted Date ICMJE | August 27, 2014 | |||
Last Update Posted Date | August 27, 2014 | |||
Study Start Date ICMJE | March 2008 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Disease Severity Success (ODS) [ Time Frame: 8 and 12 weeks ] Success was defined as a one-grade improvement in ODS from baseline.
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Original Primary Outcome Measures ICMJE |
Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score [ Time Frame: 12 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis | |||
Official Title ICMJE | A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis | |||
Brief Summary | The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis. | |||
Detailed Description | Same as above. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Psoriasis | |||
Intervention ICMJE |
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Study Arms ICMJE | Active Comparator: Study Treatment
clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
305 | |||
Original Estimated Enrollment ICMJE |
300 | |||
Actual Study Completion Date ICMJE | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00658788 | |||
Other Study ID Numbers ICMJE | US10085 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Galderma Laboratories, L.P. | |||
Study Sponsor ICMJE | Galderma Laboratories, L.P. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Galderma Laboratories, L.P. | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |