NCT00865267

The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ultravate® 0.05% ointment, single exposure	A: Experimental Subjects received Bristol-Myers Squibb Company formulated products

Timeline

• Start date: 2003-12-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States