Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

• Registration Number: NCT01290198
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods for the study of functional microcirculation.

Detailed Description

The EETY study is a single-center proof of concept study in healthy volunteers. The main objective is to study the involvement of epoxy-eicosatrienoic acids (EETs) in the reactivity of cutaneous microcirculation during post-occlusive hyperemia and thermal hyperemia, by studying the response to microdialysis of fluconazole (an inhibitor of EETs) versus control, on the forearm.

Response is measured by the amplitude of the post-occlusive hyperemia and thermal hyperemia peaks (maximum amplitude as a percentage of maximal vasodilation and areas under the curve: AUC) during the injection of fluconazole compared to an intradermal injection of solvent (NaCl 9 ‰).

The subjects are healthy volunteers of both sexes, aged between 18 and 35, non-smokers and in good health. Over two years, 30 subjects will be included in the study for 6 to 13 weeks.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age between 18 and 35 years
• Affiliated to the French social security system or beneficiary a similar regime
• In good health

Exclusion Criteria

• Active smoker
• Pregnant, parturient, breast-feeding
• Person deprived of civil liberties by judicial or administrative measure; person under legal protection,
• Minor less than 18 years
• Within period exclusion for other clinical research studies
• Person has exceeded the annual compensation for participation in trials
• Person with active disease or with prolonged treatment, excluding oral contraceptives and paracetamol
• Asthma, urticaria, angioedema, known drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole with ANESDERM (lidocaine, prilocaine)	Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)	-
Vehicle with ANESDERM (lidocaine, prilocaine)	Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)	-
Fluconazole without ANESDERM (lidocaine, prilocaine)	Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)	-
Vehicle without ANESDERM (lidocaine, prilocaine)	Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)	-

Primary Outcome Measures

Name	Time	Method
Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰)	2 hours	maximum amplitude as a percentage of maximal vasodilation and area under the curve: AUC

Secondary Outcome Measures

Name	Time	Method
Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without N(G)-nitro-L-arginine-methyl ester (L-NMMA)	2 hours	maximum amplitude expressed as percentage of maximal vasodilation and AUC
Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰)	2 hours	maximum amplitude expressed as percentage of maximal vasodilation and AUC
Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without ANESDERM ® (lidocaine, prilocaine)	2 hours	maximum amplitude expressed as percentage of maximal vasodilation and AUC

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇫🇷 Grenoble, France