Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

Phase 1

• Conditions: Scleroderma, Systemic
• Interventions: Drug: Cutaneous iontophoresis of treprostinil

• Registration Number: NCT01554540
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-15
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18
• Primary Completion: 2013-10
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cutaneous iontophoresis of Treprostenil	Cutaneous iontophoresis of treprostinil	-
Cutaneous iontophoresis of placebo	Cutaneous iontophoresis of treprostinil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treprostinil blood concentration	0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h	AUC of treprostinil concentration from the end of iontophoresis until 10 hours after iontophoresis
Treprostinil dermal concentration	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

Trial Locations

Locations (1)

CIC pharmacology - University Hopsital of Grenoble; 🇫🇷 Grenoble, France