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

This study has been completed.
Sponsor:
Information provided by:
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00803218
First received: December 2, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Healthy
Drug: Fluticasone Propionate 0.005% Ointment-Reference Product
Drug: Fluticasone Propionate 0.005% Ointment-Test product

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments

Resource links provided by NLM:


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 ]

Enrollment: 56
Study Start Date: November 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Group 1
Subjects number 1 to 26
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
Cohort Group 2
Subjects number 27 to 56
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

  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
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Linda Gans, Perrigo
ClinicalTrials.gov Identifier: NCT00803218     History of Changes
Other Study ID Numbers: 10216916
Study First Received: December 2, 2008
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
Bioequivalence
Fluticasone Propionate

Additional relevant MeSH terms:
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 22, 2014