Overview

This trial is active, not recruiting.

Condition scleroderma, systemic
Treatment cutaneous iontophoresis of treprostinil
Phase phase 1/phase 2
Sponsor University Hospital, Grenoble
Start date February 2012
End date October 2013
Trial size 40 participants
Trial identifier NCT01554540, DCIC TIPPS 11 18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 treprostinil
Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).

Primary Outcomes

Measure
Area under the curve (AUC) of cutaneous blood flow
time frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h

Secondary Outcomes

Measure
Treprostinil blood concentration
time frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Treprostinil dermal concentration
time frame: 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Cutaneous systemic scleroderma with sclerosed fingers Exclusion Criteria: - pregnant or breast-feeding women - any chronic disease (in the control group) - smoking

Additional Information

Official title Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers
Principal investigator Jean-Luc Cracowski, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.