Healthy
Conditions
Keywords
Bioequivalence, Clobetasol Propionate
Brief summary
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.
Interventions
DRUGClobetasol Propionate 0.05% Foam-Reference Product
Small amount applied and evaluated over the course of two days
DRUGClobetasol Propionate 0.05% Foam-Test product
Small amount applied and evaluated over the course of two days
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 * Body Mass Index (BMI) of 30 or less * 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 on 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 tobacco products in the 30 days prior to study dosing * Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of 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 two days |
Outcome results
None listed