<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02183779</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC 14 02</org_study_id>
    <nct_id>NCT02183779</nct_id>
  </id_info>
  <brief_title>PORH and Response to Cold in Raynaud's Phenomenon.</brief_title>
  <acronym>REFRAIN</acronym>
  <official_title>Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids&#xD;
      (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud&#xD;
      phenomena and healthy volunteers, by studying hyperaemic postocclusive response after&#xD;
      microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the study is to determine if implication of epoxy-eicosatriénoïques&#xD;
      acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with&#xD;
      Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after&#xD;
      microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.&#xD;
&#xD;
      Healthy controls and patients will undergo 3 visits&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>post occlusive hyperemia amplitude</measure>
    <time_frame>day 1</time_frame>
    <description>post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post occlusive hyperemia amplitude with anesthetic treatment</measure>
    <time_frame>day1</time_frame>
    <description>post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cold-induced vasoconstriction amplitude</measure>
    <time_frame>day 2</time_frame>
    <description>cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cold-induced vasoconstriction amplitude with anesthetic treatment</measure>
    <time_frame>day 2</time_frame>
    <description>cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Raynaud Disease</condition>
  <condition>Hyperemia</condition>
  <condition>Cold</condition>
  <arm_group>
    <arm_group_label>Reynaud</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with reynaud phenomena</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>post-occlusive hyperemia</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Reynaud</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cooling box</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Reynaud</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-NMMA and Fluconazole dermic injection</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Reynaud</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neither raynaud's phenomenon or chronic disease for healthy volunteers&#xD;
&#xD;
          -  Raynaud's phenomenon without connective tissue disease for patients in the group&#xD;
             &quot;Raynaud&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of axillary dissection , trauma or surgery&#xD;
&#xD;
          -  History of thromboembolic disease or thrombophilia&#xD;
&#xD;
          -  Minor or law-protected major&#xD;
&#xD;
          -  Exclusion period in another study&#xD;
&#xD;
          -  No affiliation to medicare&#xD;
&#xD;
          -  Pregnant, parturient or breasting woman&#xD;
&#xD;
          -  Concomitant serious disease: progressive cancer, liver failure, history of myocardial&#xD;
             infarction less than 5 years, angor&#xD;
&#xD;
          -  Smoking in the 6 last months&#xD;
&#xD;
          -  Person deprived of liberty by a legal or administrative decision, person under legal&#xD;
             protection&#xD;
&#xD;
          -  Maximal annual indemnification reached.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Luc CRACOWSKI, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM + University Hospital Grenoble</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Luc CRACOWSKI, MD-PhD</last_name>
    <phone>+33476769260</phone>
    <email>JLCracowski@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu ROUSTIT, PharmD-PhD</last_name>
    <phone>+33476769260</phone>
    <email>MRoustit@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre d'investigation clinique CIC1406</name>
      <address>
        <city>GRENOBLE cedex9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc CRACOWSKI, MD-PhD</last_name>
      <phone>33476769260</phone>
      <email>JLCracowski@chu-grenoble.fr</email>
    </contact>
    <contact_backup>
      <last_name>PARIS Adeline, PharmD-PhD</last_name>
      <phone>33476767383</phone>
      <email>AParis@chu-grenoble.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Jean-Luc CRACOWSKI, MD-PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>December 8, 2015</last_update_submitted>
  <last_update_submitted_qc>December 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>post-occlusive hyperaemia</keyword>
  <keyword>laser-speckle contrast imaging</keyword>
  <keyword>epoxyeicosatrienoic acid</keyword>
  <keyword>nitrous oxide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperemia</mesh_term>
    <mesh_term>Raynaud Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02183779
org study id: DCIC 14 02
nct id: NCT02183779
lead sponsor: 
has dmc: Yes
The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids
      (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud
      phenomena and healthy volunteers, by studying hyperaemic postocclusive response after
      microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
The main objective of the study is to determine if implication of epoxy-eicosatriénoïques
      acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with
      Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after
      microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

      Healthy controls and patients will undergo 3 visits
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: post occlusive hyperemia amplitude
time frame: day 1
description: post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
measure: post occlusive hyperemia amplitude with anesthetic treatment
time frame: day1
description: post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic
measure: cold-induced vasoconstriction amplitude
time frame: day 2
description: cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
measure: cold-induced vasoconstriction amplitude with anesthetic treatment
time frame: day 2
description: cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment
arm group label: Reynaud
arm group type: Experimental
description: patients with reynaud phenomena
arm group label: Healthy
arm group type: Experimental
description: Healthy volunteers
intervention type: Procedure
intervention name: post-occlusive hyperemia
arm group label: Healthy
arm group label: Reynaud
intervention type: Procedure
intervention name: cooling box
arm group label: Healthy
arm group label: Reynaud
intervention type: Drug
intervention name: L-NMMA and Fluconazole dermic injection
arm group label: Healthy
arm group label: Reynaud
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Luc CRACOWSKI, MD-PhD
role: Principal Investigator
affiliation: INSERM + University Hospital Grenoble
last name: Jean-Luc CRACOWSKI, MD-PhD
phone: +33476769260
email: JLCracowski@chu-grenoble.fr
last name: Matthieu ROUSTIT, PharmD-PhD
phone: +33476769260
email: MRoustit@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Hyperemia
mesh term: Raynaud Disease
mesh term: Fluconazole