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

NCT00803218 | Completed

• 1 other identifier: 10216916
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Bioequivalence; Fluticasone Propionate

Outcome Measures

Primary Outcomes (1)

• Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter

  Over the course of one day

Study Arms (2)

Cohort Group 1

Subjects number 1 to 26

Drug: Fluticasone Propionate 0.005% Ointment-Reference Product; Drug: Fluticasone Propionate 0.005% Ointment-Test product

Cohort Group 2

Subjects number 27 to 56

Drug: Fluticasone Propionate 0.005% Ointment-Reference Product; Drug: Fluticasone Propionate 0.005% Ointment-Test product

Interventions

Fluticasone Propionate 0.005% Ointment-Reference Product DRUG

Small amount applied and evaluated over the course of one day

Cohort Group 1; Cohort Group 2

Fluticasone Propionate 0.005% Ointment-Test product DRUG

Small amount applied and evaluated over the course of one day

Cohort Group 1; Cohort Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Community Volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: October 15, 2021

Record last verified: 2021-10