Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers (INFLUX-VS)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Healthy

Treatments: Drug: sildenafil; Drug: nitroprussiate iontophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT00710099

DCIC/08/08

Details and patient eligibility

About

Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Full description

The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age over 18
• No significant medical history

Exclusion criteria

• Age under 18
• Period of exclusion for an other study
• Pregnancy
• Breast feeding
• Severe disease
• Cigarette smoking

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: sildenafil

2

Active Comparator group

Description:

SNP iontophoresis

Treatment:

Drug: nitroprussiate iontophoresis