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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00803439
• Collaborator: (none)
• Enrollment: 80

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Clobetasol Propionate 0.05% Foam-Reference Product; Drug: Clobetasol Propionate 0.05% Foam-Test product

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Foams
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter [Over the course of two days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT00803439
• Other Study ID Numbers: 10416918
• First Posted: Dec 5, 2008
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Padagis LLC: Bioequivalence; Clobetasol Propionate
• Additional relevant MeSH terms: Clobetasol

Study Results

No Results Posted as of Oct 15, 2021