Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams

Completed

• Conditions: Healthy
• Interventions: Drug: Fluticasone Propionate 0.05% Cream-Reference Product; Drug: Fluticasone Propionate 0.05% Cream-Test product

• Registration Number: NCT00803465
• Lead Sponsor: Padagis LLC

Brief Summary

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Group 4	Fluticasone Propionate 0.05% Cream-Reference Product	Subjects number 69 to 91
Cohort Group 5	Fluticasone Propionate 0.05% Cream-Reference Product	Subjects Number 92 to 115
Cohort Group 3	Fluticasone Propionate 0.05% Cream-Test product	Subjects number 45 to 68
Cohort Group 4	Fluticasone Propionate 0.05% Cream-Test product	Subjects number 69 to 91
Cohort Group 5	Fluticasone Propionate 0.05% Cream-Test product	Subjects Number 92 to 115
Cohort Group 1	Fluticasone Propionate 0.05% Cream-Test product	Subjects number 1 to 24
Cohort Group 2	Fluticasone Propionate 0.05% Cream-Test product	Subjects number 25 to 44
Cohort Group 3	Fluticasone Propionate 0.05% Cream-Reference Product	Subjects number 45 to 68
Cohort Group 2	Fluticasone Propionate 0.05% Cream-Reference Product	Subjects number 25 to 44
Cohort Group 1	Fluticasone Propionate 0.05% Cream-Reference Product	Subjects number 1 to 24

Primary Outcome Measures

Name	Time	Method
Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter	Over the course of two days