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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01290198

DCIC 10 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 4 patient groups, including a placebo group

Vehicle without ANESDERM (lidocaine, prilocaine)

Placebo Comparator group

Treatment:

Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Vehicle with ANESDERM (lidocaine, prilocaine)

Active Comparator group

Treatment:

Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Fluconazole without ANESDERM (lidocaine, prilocaine)

Active Comparator group

Treatment:

Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Fluconazole with ANESDERM (lidocaine, prilocaine)

Active Comparator group

Treatment:

Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)