Healthy
Conditions
Keywords
bioequivalence, betamethasone dipropionate, Bioequivalency
Brief summary
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.
Interventions
Small amount applied and evaluated over the course of several hours
Sponsors
Padagis LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed