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

Sponsored by Padagis LLC

About this trial

Last updated 4 years ago

Study ID

10216925

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 50 Years
Female
Female

Trial Timing

Ended 22 years ago

What is this trial about?

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.

What are the participation requirements?

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

No

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