Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00802958
- Lead Sponsor
- Padagis LLC
- Brief Summary
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
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 1 Halobetasol Propionate 0.05% Ointment-Reference Product Subjects number 1 to 30 Cohort Group 2 Halobetasol Propionate 0.05% Ointment-Reference Product Subjects number 31 to 56 Cohort Group 1 Halobetasol Propionate 0.05% Ointment-Test Product Subjects number 1 to 30 Cohort Group 2 Halobetasol Propionate 0.05% Ointment-Test Product Subjects number 31 to 56 Cohort Group 3 Halobetasol Propionate 0.05% Ointment-Reference Product Subject Numbers 57 to 76 Cohort Group 3 Halobetasol Propionate 0.05% Ointment-Test Product Subject Numbers 57 to 76
- 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 a day
- Secondary Outcome Measures
Name Time Method