Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

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.

Timeline

Start

2012-02

Primary completion

2013-10

Completion

2014-02

Publications

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

Drugs

Indications