Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802958
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Padagis LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Drug: Halobetasol Propionate 0.05% Ointment-Reference Product Drug: Halobetasol Propionate 0.05% Ointment-Test Product

Layout table for study information
Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments
Study Start Date : July 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Community Volunteers
Criteria

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
Layout table for additonal information
Responsible Party: Padagis LLC
ClinicalTrials.gov Identifier: NCT00802958    
Other Study ID Numbers: 10216913
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Keywords provided by Padagis LLC:
Bioequivalence
Halobetasol Propionate
Additional relevant MeSH terms:
Layout table for MeSH terms
Clobetasol
Halobetasol
Vasoconstrictor Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs