Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NaCl 0.9%; Drug: treprostinil; Drug: iloprost

• Registration Number: NCT01082484
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy volunteers
• age above 18

Exclusion Criteria

• any chronic disease
• any drug intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9%	NaCl 0.9%	-
Treprostinil	treprostinil	Treprostinil iontophoresis (250, 25 and 2.5 microM)
Iloprost	iloprost	Iloprost iontophoresis (200, 20 and 2 microM)

Primary Outcome Measures

Name	Time	Method
Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging	24 hours

Secondary Outcome Measures

Name	Time	Method
Local tolerance assessed clinically	Day 0 and after 7 days

Trial Locations

Locations (1)

Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble; 🇫🇷 Grenoble, France