Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00803439
- Lead Sponsor
- Padagis LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Group 1 Clobetasol Propionate 0.05% Foam-Reference Product Subjects number 1 to 20 Cohort Group 1 Clobetasol Propionate 0.05% Foam-Test product Subjects number 1 to 20 Cohort Group 2 Clobetasol Propionate 0.05% Foam-Reference Product Subjects number 21 to 40 Cohort Group 2 Clobetasol Propionate 0.05% Foam-Test product Subjects number 21 to 40 Cohort Group 3 Clobetasol Propionate 0.05% Foam-Reference Product Subjects number 41 to 60 Cohort Group 3 Clobetasol Propionate 0.05% Foam-Test product Subjects number 41 to 60 Cohort Group 4 Clobetasol Propionate 0.05% Foam-Reference Product Subjects number 61 to 80 Cohort Group 4 Clobetasol Propionate 0.05% Foam-Test product Subjects number 61 to 80
- 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
- Secondary Outcome Measures
Name Time Method