Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams
NCT ID: NCT00803166
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2004-01-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort Group 1
Subjects number 1 to 30
Halobetasol Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test product 1
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test Product 2
Small amount applied and evaluated over the course of three days
Cohort Group 2
Subjects number 31 to 60
Halobetasol Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test product 1
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test Product 2
Small amount applied and evaluated over the course of three days
Interventions
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Halobetasol Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test product 1
Small amount applied and evaluated over the course of three days
Halobetasol Propionate 0.05% Cream-Test Product 2
Small amount applied and evaluated over the course of three days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Padagis LLC
INDUSTRY
Responsible Party
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Other Identifiers
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10316926
Identifier Type: -
Identifier Source: org_study_id