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Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

NCT ID: NCT01082484

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treprostinil

Treprostinil iontophoresis (250, 25 and 2.5 microM)

Group Type EXPERIMENTAL

treprostinil

Intervention Type DRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Iloprost

Iloprost iontophoresis (200, 20 and 2 microM)

Group Type EXPERIMENTAL

iloprost

Intervention Type DRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

NaCl 0.9%

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Interventions

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treprostinil

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Intervention Type DRUG

iloprost

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Intervention Type DRUG

NaCl 0.9%

Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers
* age above 18

Exclusion Criteria

* any chronic disease
* any drug intake
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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Blaise S, Roustit M, Hellmann M, Millet C, Cracowski JL. Cathodal iontophoresis of treprostinil induces a sustained increase in cutaneous blood flux in healthy volunteers. J Clin Pharmacol. 2013 Jan;53(1):58-66. doi: 10.1177/0091270011434352. Epub 2013 Jan 24.

Reference Type DERIVED
PMID: 23400744 (View on PubMed)

Other Identifiers

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2009-016301-42

Identifier Type: -

Identifier Source: org_study_id