Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
Overview
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.
Full Title of Study: “Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 2002
Interventions
- Drug: Fluticasone Propionate 0.005% Ointment-Reference Product
- Small amount applied and evaluated over the course of one day
- Drug: Fluticasone Propionate 0.005% Ointment-Test product
- Small amount applied and evaluated over the course of one day
Arms, Groups and Cohorts
- Cohort Group 1
- Subjects number 1 to 26
- Cohort Group 2
- Subjects number 27 to 56
Clinical Trial Outcome Measures
Primary 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
Participating in This Clinical Trial
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 Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Padagis LLC
- Provider of Information About this Clinical Study
- Sponsor
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.