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

Padagis

Status

Completed

Conditions

Healthy

Treatments

Drug: Halobetasol Propionate 0.05% Ointment-Reference Product

Drug: Halobetasol Propionate 0.05% Ointment-Test Product

Study type

Observational

Funder types

Industry

Identifiers

NCT00802958

10216913

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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