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

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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

Study Description
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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

Study Design
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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

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Groups and Cohorts
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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:
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Clobetasol
Halobetasol
Vasoconstrictor Agents
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs