MedTrace Logo

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

NCT00864500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-07-09

No results posted yet for this study

Summary

To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Soran Hong,, M.D. · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864500 on ClinicalTrials.gov