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Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

NCT01554540 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-07-18

No results posted yet for this study

Summary

The purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.

Conditions

  • Scleroderma, Systemic

Interventions

DRUG

Cutaneous iontophoresis of treprostinil

Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Luc Cracowski, MD · INSERM 003

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-10-31
Completion
2014-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554540 on ClinicalTrials.gov