Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
NCT ID: NCT00803465
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
115 participants
OBSERVATIONAL
2003-04-30
2003-06-30
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 24
Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Cohort Group 2
Subjects number 25 to 44
Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Cohort Group 3
Subjects number 45 to 68
Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Cohort Group 4
Subjects number 69 to 91
Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Cohort Group 5
Subjects Number 92 to 115
Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Interventions
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Fluticasone Propionate 0.05% Cream-Reference Product
Small amount applied and evaluated over the course of two days
Fluticasone Propionate 0.05% Cream-Test product
Small amount applied and evaluated over the course of two days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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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10316906
Identifier Type: -
Identifier Source: org_study_id