Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Halobetasol Propionate 0.05% Ointment-Reference Product (Drug); Halobetasol Propionate 0.05% Ointment-Test Product (Drug)
Phase: N/A
Status: Completed
Sponsored by: Perrigo Company
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.
Clinical Details
Official title: Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2003
Last updated: March 15, 2012
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