Status:
COMPLETED
Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Lead Sponsor:
Padagis LLC
Conditions:
Healthy
Eligibility:
FEMALE
18-50 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00802958
Start Date
July 1 2003
End Date
August 1 2003
Last Update
October 15 2021
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