Overview

Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Padagis LLC
Perrigo Company
Treatments:
Clobetasol
Halobetasol
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