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Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 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: Betamethasone Dipropionate 0.05% Cream (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Perrigo Company


The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0. 05% cream in healthy, female subjects.

Clinical Details

Official title: Bioequivalence of Two Augmented Betamethasone Dipropionate 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.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.


Inclusion Criteria:

- Non-tobacco-using female subjects, 18 to 50 years of age

- Demonstrated blanching response to Reference Drug (augmented

betamethasone dipropionate) Cream 0. 05%

- Weight within + or - 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 dermatological drug therapy on the flexor surface of the forearms within

30 days of dosing

- Use of any tobacco products in the 30 days prior to study 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: December 2002
Last updated: March 15, 2012

Page last updated: August 23, 2015

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