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

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