Official Title: “Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams”

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.

Study Type: Observational

Study Design: Observational Model: Cohort, Time Perspective: Prospective

Study Primary Completion Date: January 2003

Intervention(s) in this Clinical Trial

• Drug: Betamethasone Dipropionate 0.05% Cream
  • Small amount applied and evaluated over the course of several hours

Arms, Groups and Cohorts in this Clinical Trial

• : Cohort Group 1
  • Subject Numbers 1 to 29
• : Cohort Group 2
  • Subject Numbers 20 to 59
• : Cohort Group 3
  • Subject Numbers 60 to 89
• : Cohort Group 4
  • Subject Numbers 90 to 116

Primary Measures

• Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter.
  • Time Frame: Over the course of one day
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Perrigo Company

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00800293

Study ID Number: 10216925

ClinicalTrials.gov Identifier: NCT00800293

Health Authority: United States: Institutional Review Board