Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments - Tabular View

Tracking Information
First Received Date ^ICMJE	December 2, 2008
Last Updated Date	December 3, 2008
Start Date ^ICMJE	November 2002
Current Primary Outcome Measures ^ICMJE (submitted: December 3, 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 NCT00803218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
Official Title ^ICMJE	Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments
Brief Summary	The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Case-Only, Prospective
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Fluticasone Propionate 0.005% Ointment-Reference Product Drug: Fluticasone Propionate 0.005% Ointment-Test product
Study Arms / Comparison Groups	Subjects number 1 to 26 Subjects number 27 to 56
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	56
Completion Date	November 2002
Primary Completion Date	November 2002 (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 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
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
Expanded Access Status

Administrative Information
NCT ID ^ICMJE	NCT00803218
Responsible Party	Linda Gans, Perrigo
Study ID Numbers ^ICMJE	10216916
Study Sponsor ^ICMJE	Perrigo Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Perrigo Company
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP