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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Grenoble Identifier:
First received: July 2, 2008
Last updated: October 5, 2011
Last verified: October 2011
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.

Condition Intervention
Healthy Drug: sildenafil Drug: nitroprussiate iontophoresis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil [ Time Frame: one hour ]

Secondary Outcome Measures:
  • To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger [ Time Frame: one hour ]

Estimated Enrollment: 40
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: sildenafil
systemic absorption of sildenafil
Active Comparator: 2
SNP iontophoresis
Drug: nitroprussiate iontophoresis
nitroprussiate iontophoresis

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00710099

Clinical Researsh Centre
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-Luc CRACOWSKI, MD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Responsible Party: University Hospital, Grenoble Identifier: NCT00710099     History of Changes
Other Study ID Numbers: DCIC/08/08
Study First Received: July 2, 2008
Last Updated: October 5, 2011

Keywords provided by University Hospital, Grenoble:
cutaneous microcirculation
Healthy volunteers

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on August 23, 2017