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

Padagis

Status: Completed

Conditions: Healthy

Treatments: Drug: Fluticasone Propionate 0.05% Cream-Test product; Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Study type: Observational

Funder types: Industry

Identifiers

NCT00803465

10316906

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

115 participants in 5 patient groups

Cohort Group 1

Description:

Subjects number 1 to 24

Treatment:

Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Drug: Fluticasone Propionate 0.05% Cream-Test product

Cohort Group 2

Description:

Subjects number 25 to 44

Treatment:

Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Drug: Fluticasone Propionate 0.05% Cream-Test product

Cohort Group 3

Description:

Subjects number 45 to 68

Treatment:

Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Drug: Fluticasone Propionate 0.05% Cream-Test product

Cohort Group 4

Description:

Subjects number 69 to 91

Treatment:

Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Drug: Fluticasone Propionate 0.05% Cream-Test product

Cohort Group 5

Description:

Subjects Number 92 to 115

Treatment:

Drug: Fluticasone Propionate 0.05% Cream-Reference Product

Drug: Fluticasone Propionate 0.05% Cream-Test product