Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams

Bioequivalence of Two Clobetasol Propionate 0.05% Topical Foams

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Drug: Clobetasol Propionate 0.05% Foam-Test product

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy Community Volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort Group 1; Subjects number 1 to 20	Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Small amount applied and evaluated over the course of two days; Drug: Clobetasol Propionate 0.05% Foam-Test product; Small amount applied and evaluated over the course of two days
Cohort Group 2; Subjects number 21 to 40	Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Small amount applied and evaluated over the course of two days; Drug: Clobetasol Propionate 0.05% Foam-Test product; Small amount applied and evaluated over the course of two days
Cohort Group 3; Subjects number 41 to 60	Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Small amount applied and evaluated over the course of two days; Drug: Clobetasol Propionate 0.05% Foam-Test product; Small amount applied and evaluated over the course of two days
Cohort Group 4; Subjects number 61 to 80	Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Small amount applied and evaluated over the course of two days; Drug: Clobetasol Propionate 0.05% Foam-Test product; Small amount applied and evaluated over the course of two days

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): April 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Bioequivalence; Clobetasol Propionate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: 10416918

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No