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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).
CIC pharmacology - University Hopsital of Grenoble
Grenoble, France
Area under the curve (AUC) of cutaneous blood flow
Cutaneous blood flow assessed with Laser Speckle Contrast Imaging (LSCI)
Time frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Treprostinil blood concentration
AUC of treprostinil concentration from the end of iontophoresis until 10 hours after iontophoresis
Time frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Treprostinil dermal concentration
AUC of treprostinil concentration in the dermis (collected with microdialysis) from the end of iontophoresis until 10 hours after iontophoresis
Time frame: 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h
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