DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams

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% Cream-Reference Product (Drug); Halobetasol Propionate 0.05% Cream-Test product 1 (Drug); Halobetasol Propionate 0.05% Cream-Test Product 2 (Drug)

Phase: N/A

Status: Completed

Sponsored by: Perrigo Company

Summary

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0. 05% Cream in healthy, female subjects.

Clinical Details

Official title: Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams

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

- Body Mass Index (BMI) of 30 or less

- 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: January 2004
Last updated: March 15, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017