Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions
Overview
The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.
Full Title of Study: “Bioequivalence of Three Mometasone Furoate 0.1% Topical Lotions”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2004
Interventions
- Drug: Mometasone Furoate 0.1% Topical Lotion-Reference Product
- Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
- Drug: Mometasone Furoate 0.1% Topical Lotion-Test product 1
- Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
- Drug: Mometasone Furoate 0.1% Topical Lotion-Test Product 2
- Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
Arms, Groups and Cohorts
- Cohort Group 1
- Subjects number 1 to 20
- Cohort Group 2
- Subjects number 21 to 50
- Cohort Group 3
- Subject Numbers 51 to 80
Clinical Trial Outcome Measures
Primary Measures
- Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
- Time Frame: Over the course of two days
Participating in This Clinical Trial
Inclusion Criteria
- Non-tobacco using female subjects, 18 to 50 years of age – 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:
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Padagis LLC
- Provider of Information About this Clinical Study
- Sponsor
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