Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT00865267
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
Sponsor:
Actavis Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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).
Detailed Description:
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:
Vasoconstrictor Response
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:
Vasoconstrictor Response
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: