Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT00864500 |
Recruitment Status
:
Completed
First Posted
: March 18, 2009
Last Update Posted
: August 16, 2010
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Sponsor:
Actavis Inc.
Information provided by:
Actavis Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | March 17, 2009 | |||
First Posted Date ICMJE | March 18, 2009 | |||
Last Update Posted Date | August 16, 2010 | |||
Study Start Date ICMJE | November 2005 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Vasoconstrictor Response [ Time Frame: 24 hours ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00864500 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects | |||
Official Title ICMJE | Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions | |||
Brief Summary | To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects. | |||
Detailed Description | Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study. Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: · Vasoconstrictor Response |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms |
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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 |
224 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | February 2006 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
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 | NCT00864500 | |||
Other Study ID Numbers ICMJE | 10504910 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Christine Winslow, Director of Clinical Development, Actavis Inc | |||
Study Sponsor ICMJE | Actavis Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Actavis Inc. | |||
Verification Date | August 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |