Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams

Padagis

Status: Completed

Conditions: Healthy

Treatments: Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Drug: Clobetasol Propionate 0.05% Foam-Test product

Study type: Observational

Funder types: Industry

Identifiers

NCT00803439

10416918

Details and patient eligibility

About

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

Enrollment: 80 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
• Body Mass Index (BMI) of 30 or less
• 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 on 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

80 participants in 4 patient groups

Cohort Group 1

Description:

Subjects number 1 to 20

Treatment:

Drug: Clobetasol Propionate 0.05% Foam-Reference Product

Drug: Clobetasol Propionate 0.05% Foam-Test product

Cohort Group 2

Description:

Subjects number 21 to 40

Treatment:

Drug: Clobetasol Propionate 0.05% Foam-Reference Product

Drug: Clobetasol Propionate 0.05% Foam-Test product

Cohort Group 3

Description:

Subjects number 41 to 60

Treatment:

Drug: Clobetasol Propionate 0.05% Foam-Reference Product

Drug: Clobetasol Propionate 0.05% Foam-Test product

Cohort Group 4

Description:

Subjects number 61 to 80

Treatment:

Drug: Clobetasol Propionate 0.05% Foam-Reference Product

Drug: Clobetasol Propionate 0.05% Foam-Test product