Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study (TIPPS)

This study is ongoing, but not recruiting participants.
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01554540     History of Changes
Other Study ID Numbers: DCIC TIPPS 11 18
Study First Received: February 7, 2012
Last Updated: July 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Treprostinil
Scleroderma
Iontophoresis

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014