Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Perrigo Company

ClinicalTrials.gov Identifier:

NCT00800293

First received: November 26, 2008

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 26, 2008
Last Updated Date	March 15, 2012
Start Date ^ICMJE	December 2002
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 1, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00800293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Official Title ^ICMJE	Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Healthy Community Volunteers
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Betamethasone Dipropionate 0.05% Cream Small amount applied and evaluated over the course of several hours
Study Group/Cohort (s)	Cohort Group 1 Subject Numbers 1 to 29 Intervention: Drug: Betamethasone Dipropionate 0.05% Cream Cohort Group 2 Subject Numbers 20 to 59 Intervention: Drug: Betamethasone Dipropionate 0.05% Cream Cohort Group 3 Subject Numbers 60 to 89 Intervention: Drug: Betamethasone Dipropionate 0.05% Cream Cohort Group 4 Subject Numbers 90 to 116 Intervention: Drug: Betamethasone Dipropionate 0.05% Cream
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	116
Completion Date	January 2003
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00800293
Other Study ID Numbers ^ICMJE	10216925
Has Data Monitoring Committee	No
Responsible Party	Perrigo Company
Study Sponsor ^ICMJE	Perrigo Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Perrigo Company
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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