Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Overview
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.
Full Title of Study: “Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2003
Interventions
- Drug: Betamethasone Dipropionate 0.05% Cream
- Small amount applied and evaluated over the course of several hours
Arms, Groups and Cohorts
- 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
Clinical Trial Outcome Measures
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
Participating in This Clinical Trial
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: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Padagis LLC
- Provider of Information About this Clinical Study
- Sponsor
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