- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00800293
Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
October 8, 2021 updated by: Padagis LLC
Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
116
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
No
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 (augmented betamethasone dipropionate) Cream 0.05%
- Weight within + or - 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:
- 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 dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
- Use of any tobacco products in the 30 days prior to study 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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort Group 1
Subject Numbers 1 to 29
|
Small amount applied and evaluated over the course of several hours
|
Cohort Group 2
Subject Numbers 20 to 59
|
Small amount applied and evaluated over the course of several hours
|
Cohort Group 3
Subject Numbers 60 to 89
|
Small amount applied and evaluated over the course of several hours
|
Cohort Group 4
Subject Numbers 90 to 116
|
Small amount applied and evaluated over the course of several hours
|
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 one day
|
Over the course of one day
|
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
December 1, 2002
Primary Completion (Actual)
January 1, 2003
Study Completion (Actual)
January 1, 2003
Study Registration Dates
First Submitted
November 26, 2008
First Submitted That Met QC Criteria
December 1, 2008
First Posted (Estimate)
December 2, 2008
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 8, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
Other Study ID Numbers
- 10216925
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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