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

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00802958

Purpose

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

Condition	Intervention
Healthy	Drug: Halobetasol Propionate 0.05% Ointment-Reference Product Drug: Halobetasol Propionate 0.05% Ointment-Test Product

Drug Information available for: Halobetasol Ulobetasol

U.S. FDA Resources

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

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 a day ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	76
Study Start Date:	July 2003
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (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% Ointment-Reference Product Small amount applied and evaluated over the course of a day Drug: Halobetasol Propionate 0.05% Ointment-Test Product Small amount applied and evaluated over the course of a day
Cohort Group 2 Subjects number 31 to 56	Drug: Halobetasol Propionate 0.05% Ointment-Reference Product Small amount applied and evaluated over the course of a day Drug: Halobetasol Propionate 0.05% Ointment-Test Product Small amount applied and evaluated over the course of a day
Cohort Group 3 Subject Numbers 57 to 76	Drug: Halobetasol Propionate 0.05% Ointment-Reference Product Small amount applied and evaluated over the course of a day Drug: Halobetasol Propionate 0.05% Ointment-Test Product Small amount applied and evaluated over the course of a day

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
Weight within +/- 20% from normal for height and weight for body frame
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

Responsible Party:	Perrigo ( Linda Gans )
Study ID Numbers:	10216913
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802958
Health Authority:	United States: Food and Drug Administration

Keywords provided by Perrigo Company:

Bioequivalence
Halobetasol Propionate

Study placed in the following topic categories:

Clobetasol
Healthy
Halobetasol

Additional relevant MeSH terms:

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

Cardiovascular Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009