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...
Date First Received: July 2, 2008
Last Updated: July 3, 2008
Verified by: University Hospital, Grenoble, July 2008
Clinical Trial Phase: N/A | Start Date: July 2008
Overall Status: Recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
Study Primary Completion Date: June 2009
Detailed Clinical Trial Description
The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.
Intervention(s) in this Clinical Trial
- Drug: sildenafil
- systemic absorption of sildenafil
- Drug: nitroprussiate iontophoresis
- nitroprussiate iontophoresis
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
- SNP iontophoresis
Outcome Measures for this Clinical Trial
Primary Measures
- variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil
- Time Frame: one hour
Safety Issue?: No
- Time Frame: one hour
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Grenoble
Overall Clinical Trial Officials and Contacts
Jean-Luc CRACOWSKI, MD Principal Investigator Institut National de la Santé Et de la Recherche Médicale, France
Overall Contact: Jean-Luc CRACOWSKI, MD +33(0)476769260 JLCracowski@chu-grenoble.fr
Related Publications
References
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. Epub 2006 Jul 31. Review.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00710099
Study ID Number: DCIC/08/08
ClinicalTrials.gov Identifier: NCT00710099
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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