The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT00865267|
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : August 17, 2010
The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment.
Part A: To validate vasoconstrictor assay precision.
Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Ultravate® 0.05% ointment, single exposure||Phase 1|
Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects.
Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||December 2003|
|Actual Study Completion Date :||December 2003|
Ultravate® 0.05% ointment, single exposure
Drug: Ultravate® 0.05% ointment, single exposure
A: Experimental Subjects received Bristol-Myers Squibb Company formulated products
Other Name: Halobetasol
- Vasoconstriction response [ Time Frame: 36 hours ]
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): NCT00865267
|United States, California|
|San Diego, California, United States, 92128|
|Principal Investigator:||Paul A. Lehman,, M.Sc.||DermTech International|