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

Completed

• Conditions: Healthy
• Interventions: Drug: Betamethasone Dipropionate 0.05% Cream

• Registration Number: NCT00800293
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Group 2	Betamethasone Dipropionate 0.05% Cream	Subject Numbers 20 to 59
Cohort Group 4	Betamethasone Dipropionate 0.05% Cream	Subject Numbers 90 to 116
Cohort Group 1	Betamethasone Dipropionate 0.05% Cream	Subject Numbers 1 to 29
Cohort Group 3	Betamethasone Dipropionate 0.05% Cream	Subject Numbers 60 to 89

Primary Outcome Measures

Name	Time	Method
Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter.	Over the course of one day