Clinical trial NCT01290198: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia
Official title: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: epoxy-eicosatrienoic acid
Laser Doppler
Endothelium derived hyperpolarizing factor
cutaneous microcirculation
post-occlusive hyperaemia
thermal hyperemia
intradermal microdialysis
fluconazole
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰)
timeFrame: 2 hours
Secondary outcomes:
measure: Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰)
timeFrame: 2 hours
measure: 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)
timeFrame: 2 hours
measure: 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)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Pharmacology Unit
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Luc Cracowski, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: