HealthyNCT00803218
Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
An observational study of Healthy, run by Padagis LLC.
Trial summary
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fluticasone Propionate 0.005% Ointment-Reference Product and Fluticasone Propionate 0.005% Ointment-Test product
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Nov 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy Community Volunteers
Who may be able to join
- Non-tobacco using female subjects, 18 to 50 years of age
- 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
Who cannot join
- 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
About this study
Official title: Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
- Conditions
- Healthy
- Being tested
- Fluticasone Propionate 0.005% Ointment-Reference Product, Fluticasone Propionate 0.005% Ointment-Test product
- Keywords
- Bioequivalence, Fluticasone Propionate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate 0.005% Ointment-Reference ProductDrug
Small amount applied and evaluated over the course of one day
Fluticasone Propionate 0.005% Ointment-Test productDrug
Small amount applied and evaluated over the course of one day
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group 1 | Subjects number 1 to 26 Receives: Drug: Fluticasone Propionate 0.005% Ointment-Reference Product; Drug: Fluticasone Propionate 0.005% Ointment-Test product | |
| Cohort Group 2 | Subjects number 27 to 56 Receives: Drug: Fluticasone Propionate 0.005% Ointment-Reference Product; Drug: Fluticasone Propionate 0.005% Ointment-Test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
Measured: Over the course of one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803218
- Sponsor's protocol ID
- 10216916
- Status last verified
- Oct 2021
- First submitted
- 2 Dec 2008
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments
- ClinicalTrials.gov ID
- NCT00803218
- Acronym / sponsor ID
- 10216916
- Conditions
- Healthy
- Keywords
- Bioequivalence, Fluticasone Propionate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort Group 1 | – | Drug: Fluticasone Propionate 0.005% Ointment-Reference Product, Drug: Fluticasone Propionate 0.005% Ointment-Test productSubjects number 1 to 26 |
| Cohort Group 2 | – | Drug: Fluticasone Propionate 0.005% Ointment-Reference Product, Drug: Fluticasone Propionate 0.005% Ointment-Test productSubjects number 27 to 56 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Community Volunteers
Key inclusion criteria (5 listed)
- Non-tobacco using female subjects, 18 to 50 years of age
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate 0.005% Ointment-Reference ProductSmall amount applied and evaluated over the course of one day | Drug | Cohort Group 1, Cohort Group 2 |
| Fluticasone Propionate 0.005% Ointment-Test productSmall amount applied and evaluated over the course of one day | Drug | Cohort Group 1, Cohort Group 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Padagis LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.