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Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study (TIPPS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01554540
First received: February 7, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose
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.

Condition Intervention Phase
Scleroderma, Systemic Drug: Cutaneous iontophoresis of treprostinil Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria:

  • pregnant or breast-feeding women
  • any chronic disease (in the control group)
  • smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554540

Locations
France
CIC pharmacology - University Hopsital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc Cracowski, MD INSERM 003