Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers (INFLUX-IT-VS)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Drug: treprostinil; Drug: iloprost; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01082484

2009-016301-42

Details and patient eligibility

About

The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• age above 18

Exclusion criteria

• any chronic disease
• any drug intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups, including a placebo group

Treprostinil

Experimental group

Description:

Treprostinil iontophoresis (250, 25 and 2.5 microM)

Treatment:

Drug: treprostinil

Iloprost

Experimental group

Description:

Iloprost iontophoresis (200, 20 and 2 microM)

Treatment:

Drug: iloprost

NaCl 0.9%

Placebo Comparator group

Treatment:

Drug: NaCl 0.9%