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

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ClinicalTrials.gov Identifier: NCT01290198
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia
Study Start Date : February 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Vehicle without ANESDERM (lidocaine, prilocaine) Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)
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.
Active Comparator: Vehicle with ANESDERM (lidocaine, prilocaine) Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)
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.
Active Comparator: Fluconazole without ANESDERM (lidocaine, prilocaine) Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)
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.
Active Comparator: Fluconazole with ANESDERM (lidocaine, prilocaine) Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)
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.



Primary Outcome Measures :
  1. Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰) [ Time Frame: 2 hours ]
    maximum amplitude as a percentage of maximal vasodilation and area under the curve: AUC


Secondary Outcome Measures :
  1. Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC

  2. 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) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC

  3. 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) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290198


Locations
France
Clinical Pharmacology Unit
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc Cracowski, MD,PhD University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01290198     History of Changes
Other Study ID Numbers: DCIC 10 01
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by University Hospital, Grenoble:
epoxy-eicosatrienoic acid
Laser Doppler
Endothelium derived hyperpolarizing factor
cutaneous microcirculation
post-occlusive hyperaemia
thermal hyperemia
intradermal microdialysis
fluconazole

Additional relevant MeSH terms:
Hyperemia
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Prilocaine
Fluconazole
NG-Nitroarginine Methyl Ester
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors