Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554540

Acronym

TIPPS

Enrollment

Registered

2012-03-15

Start date

2012-02-29

Completion date

2014-02-28

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Systemic

Keywords

Treprostinil, Scleroderma, Iontophoresis

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.

Interventions

DRUGCutaneous iontophoresis of treprostinil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Cutaneous systemic scleroderma with sclerosed fingers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026