Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

NCT ID: NCT01554540

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

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.

Conditions

Scleroderma, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cutaneous iontophoresis of Treprostenil

Group Type: EXPERIMENTAL

Cutaneous iontophoresis of treprostinil

Intervention Type: DRUG

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

Cutaneous iontophoresis of placebo

Group Type: PLACEBO_COMPARATOR

Cutaneous iontophoresis of treprostinil

Intervention Type: DRUG

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

Interventions

Cutaneous iontophoresis of treprostinil

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc Cracowski, MD

Role: PRINCIPAL_INVESTIGATOR

INSERM 003

Locations

CIC pharmacology - University Hopsital of Grenoble

Grenoble, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20860718 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16876881 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 11092203 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15019750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18077494 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28387950 (View on PubMed)

Other Identifiers

DCIC TIPPS 11 18

Identifier Type: -

Identifier Source: org_study_id