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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

February 7, 2012
July 17, 2013
February 2012
October 2013   (final data collection date for primary outcome measure)
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)
AUC of cutaneous blood flow [ Time Frame: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h ] [ Designated as safety issue: No ]
Cutaneaous blood flow assessed with Laser Speckle Contrast Imaging (LSCI)
Complete list of historical versions of study NCT01554540 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study
Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Scleroderma, Systemic
Drug: Cutaneous iontophoresis of treprostinil
Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).
  • Experimental: Cutaneous iontophoresis of Treprostenil
    Intervention: Drug: Cutaneous iontophoresis of treprostinil
  • Placebo Comparator: Cutaneous iontophoresis of placebo
    Intervention: Drug: Cutaneous iontophoresis of treprostinil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
February 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria:

  • pregnant or breast-feeding women
  • any chronic disease (in the control group)
  • smoking
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01554540
DCIC TIPPS 11 18
No
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Luc Cracowski, MD INSERM 003
University Hospital, Grenoble
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP