Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams - Full Text View

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00803166

Purpose

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.

Condition	Intervention
Healthy	Drug: Halobetasol Propionate 0.05% Cream-Reference Product Drug: Halobetasol Propionate 0.05% Cream-Test product 1 Drug: Halobetasol Propionate 0.05% Cream-Test Product 2

Drug Information available for: Halobetasol Ulobetasol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter [ Time Frame: Over the course of three days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	60
Study Start Date:	January 2004
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort Group 1 Subjects number 1 to 30	Drug: Halobetasol Propionate 0.05% Cream-Reference Product Small amount applied and evaluated over the course of three days Drug: Halobetasol Propionate 0.05% Cream-Test product 1 Small amount applied and evaluated over the course of three days Drug: Halobetasol Propionate 0.05% Cream-Test Product 2 Small amount applied and evaluated over the course of three days
Cohort Group 2 Subjects number 31 to 60	Drug: Halobetasol Propionate 0.05% Cream-Reference Product Small amount applied and evaluated over the course of three days Drug: Halobetasol Propionate 0.05% Cream-Test product 1 Small amount applied and evaluated over the course of three days Drug: Halobetasol Propionate 0.05% Cream-Test Product 2 Small amount applied and evaluated over the course of three days

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy Community Volunteers

Criteria

Inclusion Criteria:

Non-tobacco using female subjects, 18 to 50 years of age
Demonstrated blanching response to Reference Drug
Body Mass Index (BMI) of 30 or less
Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

History of allergy to systemic or topical corticosteroids
Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
Presence of medical condition requiring regular treatment with prescription drugs
Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
Use of any tobacco products in the 30 days prior to study dosing
Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
Receipt of any drugs as part of a research study within 30 days prior to study dosing
Pregnant or lactating

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Perrigo ( Linda Gans )
Study ID Numbers:	10316926
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803166 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Perrigo Company:

Bioequivalence
Halobetasol Propionate

Study placed in the following topic categories:

Anti-Inflammatory Agents
Clobetasol
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Vasoconstrictor Agents

Cardiovascular Agents
Healthy
Hormones
Glucocorticoids
Halobetasol

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vasoconstrictor Agents

Cardiovascular Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Halobetasol

ClinicalTrials.gov processed this record on May 07, 2009