The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|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|
- Vasoconstriction response [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
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
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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865267
|United States, California|
|San Diego, California, United States, 92128|
|Principal Investigator:||Paul A. Lehman,, M.Sc.||DermTech International|