Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study (TIPPS)

July 17, 2013 updated by: University Hospital, Grenoble

Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Digital ulcerations are a complication of systemic sclerosis (SSc). Available treatments (i.e. IV iloprost) induce major adverse effects, limiting the use of such therapies. Iontophoresis is a non invasive route of administration of drugs. In experimental and clinical preliminary studies, the investigators have shown that iontophoresis of treprostinil on the forearm of healthy subjects induces a sustained increase in skin blood flux and that it is well tolerated (clinicaltrials.gov NCT01082484, manuscript in press). The investigators therefore aim at validating this proof of concept on the digits of SSc patients.

Study Type

Interventional

Enrollment (Anticipated)

40

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
        • CIC pharmacology - University Hopsital of 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:

  • Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria:

  • pregnant or breast-feeding women
  • any chronic disease (in the control group)
  • smoking

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cutaneous iontophoresis of Treprostenil
Drug: Cutaneous iontophoresis of treprostinil
Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).
Placebo Comparator: Cutaneous iontophoresis of placebo
Drug: Cutaneous iontophoresis of treprostinil
Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) of cutaneous blood flow
Time Frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Cutaneous blood flow assessed with Laser Speckle Contrast Imaging (LSCI)
0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treprostinil blood concentration
Time Frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
AUC of treprostinil concentration from the end of iontophoresis until 10 hours after iontophoresis
0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Treprostinil dermal concentration
Time Frame: 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h
AUC of treprostinil concentration in the dermis (collected with microdialysis) from the end of iontophoresis until 10 hours after iontophoresis
1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Luc Cracowski, MD, INSERM 003

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

February 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC TIPPS 11 18

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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