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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle without ANESDERM (lidocaine, prilocaine) | Placebo Comparator |
| |
| Vehicle with ANESDERM (lidocaine, prilocaine) | Active Comparator |
| |
| Fluconazole without ANESDERM (lidocaine, prilocaine) | Active Comparator |
| |
| Fluconazole with ANESDERM (lidocaine, prilocaine) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA) | Drug | At the first three visits, volunteers will receive fluconazole (650µmol/L and 6.5mmol/L) and vehicle (NaCl 0.9%), and at the fourth, these plus L-NMMA (10mmol/L), delivered by microdialysis in the forearm, with or without anesthesia. Then post-occlusive hyperemia and thermal hyperemia are performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰) | maximum amplitude as a percentage of maximal vasodilation and area under the curve: AUC | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰) | maximum amplitude expressed as percentage of maximal vasodilation and AUC | 2 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Cracowski, MD,PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Grenoble | 38000 | France |
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| ID | Term |
|---|---|
| D019331 | NG-Nitroarginine Methyl Ester |
| D019323 | omega-N-Methylarginine |
| ID | Term |
|---|---|
| D001120 | Arginine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
maximum amplitude expressed as percentage of maximal vasodilation and AUC |
| 2 hours |
| 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) | maximum amplitude expressed as percentage of maximal vasodilation and AUC | 2 hours |
| D000599 |
| Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |