Trials / Completed
CompletedNCT00864240
The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Dose Response of Clobex 0.05% Lotion
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Actavis Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion, 0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a full bioequivalence study.
Detailed description
Study Type: Interventional Study Design: Randomized, open label, one period, dose response, vasoconstrictor assay study. Official Title: Dose Response of Clobex 0.05% Lotion Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: · Vasoconstrictor Response
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clobex TM (Clobetasol) 0.05% Lotion, single exposure | Subjects received Galderma Laboratories, L.P. formulated products |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2005-10-01
- Completion
- 2005-10-01
- First posted
- 2009-03-18
- Last updated
- 2019-07-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00864240. Inclusion in this directory is not an endorsement.