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Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers (INFLUX-IT-VS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01082484
First received: February 9, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: treprostinil
Drug: iloprost
Drug: NaCl 0.9%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tolerance assessed clinically [ Time Frame: Day 0 and after 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: NaCl 0.9% Drug: NaCl 0.9%
Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • age above 18

Exclusion Criteria:

  • any chronic disease
  • any drug intake
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082484

Locations
France
Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01082484     History of Changes
Other Study ID Numbers: 2009-016301-42
Study First Received: February 9, 2010
Last Updated: October 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Healthy volunteers
iontophoresis

Additional relevant MeSH terms:
Iloprost
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014