Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments
1 other identifier
observational
76
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2003
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedOctober 15, 2021
October 1, 2021
1 month
December 4, 2008
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
Over the course of a day
Study Arms (3)
Cohort Group 1
Subjects number 1 to 30
Cohort Group 2
Subjects number 31 to 56
Cohort Group 3
Subject Numbers 57 to 76
Interventions
Small amount applied and evaluated over the course of a day
Small amount applied and evaluated over the course of a day
Eligibility Criteria
Healthy Community Volunteers
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
July 1, 2003
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
October 15, 2021
Record last verified: 2021-10