- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082484
Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers (INFLUX-IT-VS)
October 5, 2011 updated by: University Hospital, Grenoble
The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France, 38043
- Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy volunteers
- age above 18
Exclusion Criteria:
- any chronic disease
- any drug intake
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: NaCl 0.9%
|
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
|
Experimental: Treprostinil
Treprostinil iontophoresis (250, 25 and 2.5 microM)
|
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
|
Experimental: Iloprost
Iloprost iontophoresis (200, 20 and 2 microM)
|
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local tolerance assessed clinically
Time Frame: Day 0 and after 7 days
|
Day 0 and after 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
February 9, 2010
First Submitted That Met QC Criteria
March 5, 2010
First Posted (Estimate)
March 8, 2010
Study Record Updates
Last Update Posted (Estimate)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 5, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-016301-42
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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