Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Betamethasone Dipropionate 0.05% Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort Group 1<br>Subject Numbers 1 to 29 | Drug: Betamethasone Dipropionate 0.05% Cream<br>* Small amount applied and evaluated over the course of several hours<br>|
| Cohort Group 2<br>Subject Numbers 20 to 59 | Drug: Betamethasone Dipropionate 0.05% Cream<br>* Small amount applied and evaluated over the course of several hours<br>|
| Cohort Group 3<br>Subject Numbers 60 to 89 | Drug: Betamethasone Dipropionate 0.05% Cream<br>* Small amount applied and evaluated over the course of several hours<br>|
| Cohort Group 4<br>Subject Numbers 90 to 116 | Drug: Betamethasone Dipropionate 0.05% Cream<br>* Small amount applied and evaluated over the course of several hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter. |  | Over the course of one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, betamethasone dipropionate, Bioequivalency