NCT01554540

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

February 7, 2012

Last Update Submit

July 17, 2013

Conditions

Scleroderma, Systemic

Keywords

TreprostinilSclerodermaIontophoresis

Outcome Measures

Primary Outcomes (1)

  • Area under the curve (AUC) of cutaneous blood flow

    Cutaneous blood flow assessed with Laser Speckle Contrast Imaging (LSCI)

    0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h

Secondary Outcomes (2)

  • Treprostinil blood concentration

    0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h

  • Treprostinil dermal concentration

    1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h

Study Arms (2)

Cutaneous iontophoresis of Treprostenil

EXPERIMENTAL
Drug: Cutaneous iontophoresis of treprostinil

Cutaneous iontophoresis of placebo

PLACEBO COMPARATOR
Drug: Cutaneous iontophoresis of treprostinil

Interventions

Cutaneous iontophoresis of treprostinilDRUG

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

Cutaneous iontophoresis of TreprostenilCutaneous iontophoresis of placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cutaneous systemic scleroderma with sclerosed fingers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC pharmacology - University Hopsital of Grenoble

Grenoble, 38043, France

Location

Related Publications (6)

  • Blaise S, Roustit M, Millet C, Ribuot C, Boutonnat J, Cracowski JL. Cathodal iontophoresis of treprostinil and iloprost induces a sustained increase in cutaneous flux in rats. Br J Pharmacol. 2011 Feb;162(3):557-65. doi: 10.1111/j.1476-5381.2010.01045.x.

    PMID: 20860718BACKGROUND

  • Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. doi: 10.1016/j.tips.2006.07.008. Epub 2006 Jul 31.

    PMID: 16876881BACKGROUND

  • Herrick AL. Vascular function in systemic sclerosis. Curr Opin Rheumatol. 2000 Nov;12(6):527-33. doi: 10.1097/00002281-200011000-00009.

    PMID: 11092203BACKGROUND

  • Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. doi: 10.1016/j.addr.2003.10.026.

    PMID: 15019750BACKGROUND

  • Murray AK, Moore TL, King TA, Herrick AL. Vasodilator iontophoresis a possible new therapy for digital ischaemia in systemic sclerosis? Rheumatology (Oxford). 2008 Jan;47(1):76-9. doi: 10.1093/rheumatology/kem314.

    PMID: 18077494BACKGROUND

  • Gaillard-Bigot F, Roustit M, Jourdil JF, Stanke-Labesque F, Cracowski JL. Vascular Effects of Treprostinil Cutaneous Iontophoresis on the Leg, Finger, and Foot. J Clin Pharmacol. 2017 Sep;57(9):1215-1220. doi: 10.1002/jcph.898. Epub 2017 Apr 7. No abstract available.

    PMID: 28387950DERIVED

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Jean-Luc Cracowski, MD

    INSERM 003

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 15, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

February 1, 2014

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

FR(1)