- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805155
Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions
October 7, 2021 updated by: Padagis LLC
Bioequivalence of Three Mometasone Furoate 0.1% Topical Lotions
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy Community Volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort Group 1
Subjects number 1 to 20
|
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
|
Cohort Group 2
Subjects number 21 to 50
|
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
|
Cohort Group 3
Subject Numbers 51 to 80
|
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
Small amount applied and evaluated over the course of two days.
ChromaMeter used to measure response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Over the course of two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (ACTUAL)
March 1, 2004
Study Completion (ACTUAL)
March 1, 2004
Study Registration Dates
First Submitted
December 5, 2008
First Submitted That Met QC Criteria
December 8, 2008
First Posted (ESTIMATE)
December 9, 2008
Study Record Updates
Last Update Posted (ACTUAL)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10316908
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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