Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments

October 7, 2021 updated by: Padagis LLC

Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

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
  • Weight within +/- 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort Group 1
Subjects number 1 to 30
Drug: Halobetasol Propionate 0.05% Ointment-Reference Product
Small amount applied and evaluated over the course of a day
Drug: Halobetasol Propionate 0.05% Ointment-Test Product
Small amount applied and evaluated over the course of a day
Cohort Group 2
Subjects number 31 to 56
Drug: Halobetasol Propionate 0.05% Ointment-Reference Product
Small amount applied and evaluated over the course of a day
Drug: Halobetasol Propionate 0.05% Ointment-Test Product
Small amount applied and evaluated over the course of a day
Cohort Group 3
Subject Numbers 57 to 76
Drug: Halobetasol Propionate 0.05% Ointment-Reference Product
Small amount applied and evaluated over the course of a day
Drug: Halobetasol Propionate 0.05% Ointment-Test Product
Small amount applied and evaluated over the course of a day

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
Time Frame: Over the course of a day
Over the course of a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Padagis LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

August 1, 2003

Study Completion (ACTUAL)

August 1, 2003

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10216913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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