NCT00864500

Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clobetasol Propionate 0.05% lotion, single exposure	A: Experimental Subjects received Alpharma USPD, Inc formulated products
DRUG	Clobex TM 0.05% Lotion, single exposure	B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2009-03-18
• Last updated: 2019-07-09

Locations

1 site across 1 country: United States