Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams - Full Text View

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00800293

Purpose

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.

Condition	Intervention	Phase
Healthy	Drug: Betamethasone Dipropionate 0.05% Cream	Phase I

Drug Information available for: Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Bioequivalence of Two Augmented Betamethasone Dipropionate 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 one day ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	116
Study Start Date:	December 2002
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort Group 1 Subject Numbers 1 to 29	Drug: Betamethasone Dipropionate 0.05% Cream Small amount applied and evaluated over the course of several hours
Cohort Group 2 Subject Numbers 20 to 59	Drug: Betamethasone Dipropionate 0.05% Cream Small amount applied and evaluated over the course of several hours
Cohort Group 3 Subject Numbers 60 to 89	Drug: Betamethasone Dipropionate 0.05% Cream Small amount applied and evaluated over the course of several hours
Cohort Group 4 Subject Numbers 90 to 116	Drug: Betamethasone Dipropionate 0.05% Cream Small amount applied and evaluated over the course of several hours

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 (augmented betamethasone dipropionate) Cream 0.05%
Weight within + or - 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 dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
Use of any tobacco products in the 30 days prior to study 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:	10216925
Study First Received:	November 26, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00800293
Health Authority:	United States: Institutional Review Board

Keywords provided by Perrigo Company:

bioequivalence
betamethasone dipropionate
Bioequivalency

Study placed in the following topic categories:

Betamethasone-17,21-dipropionate
Sodium phosphate
Betamethasone sodium phosphate
Healthy
Betamethasone

Additional relevant MeSH terms:

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

Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009