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

  • France
      • 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%
Drug: NaCl 0.9%
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
Experimental: Treprostinil
Treprostinil iontophoresis (250, 25 and 2.5 microM)
Drug: treprostinil
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
Experimental: Iloprost
Iloprost iontophoresis (200, 20 and 2 microM)
Drug: iloprost
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

University Hospital, Grenoble

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.

General Publications

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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