xml: <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/NCT05984641</url>
    </required_header>
    <id_info>
      <org_study_id>CONAN2019</org_study_id>
      <nct_id>NCT05984641</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease</brief_title>
    <official_title>Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Omikron Italia S.r.l.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Omikron Italia S.r.l.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological&#xD;
        Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of&#xD;
        haemorrhoidal disease and anal fissures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin&#xD;
        and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its&#xD;
        potential efficacy in reducing related symptoms.&#xD;
  &#xD;
        Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them,&#xD;
        20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the&#xD;
        untreated control group (Group B). At each scheduled visit, total symptoms were assessed and&#xD;
        recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events&#xD;
        reported by study subjects were also assessed and recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">September 30, 2022</completion_date>
    <primary_completion_date type="Actual">August 29, 2022</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>
      <intervention_model_description>The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the symptom numerical rating scale</measure>
      <time_frame>30 days</time_frame>
      <description>The primary outcome was the change in the symptom numerical rating scale (NRS) score after one month (V3) of treatment compared to the baseline in the two groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety and Treatment compliance</measure>
      <time_frame>30 days</time_frame>
      <description>The safety of the treatment was investigated by recording and systemic and local adverse events such as systemic allergic reactions, skin sensitisation and discomfort, etc. Treatment compliance was evaluated through assessment by the investigator of the empty study treatment cream tubes returned by patients at the end of the study.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Hemorrhoid Pain</condition>
    <condition>Haemorrhoid Inflammation</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CONAN® Proctological Cream</intervention_name>
      <description>The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 18 and 70 years&#xD;
  &#xD;
            -  Hemorrhoidal pathology, anal fissures and anitis&#xD;
  &#xD;
            -  NRS score ≥ 3 for at least one of the symptoms (burning, itching, feeling of&#xD;
               heaviness, foreign body)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known hypersensitivity to study products&#xD;
  &#xD;
            -  Proctitis&#xD;
  &#xD;
            -  Current therapy with other local treatments based on phlebotropes and/or&#xD;
               anti-inflammatories&#xD;
  &#xD;
            -  Surgical treatments undergone less than a year after inclusion&#xD;
  &#xD;
            -  Pregnancy, breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gabriella Giarratano</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Policlinico Tor Vergata Foundation (PTV)</name>
        <address>
          <city>Rome</city>
          <zip>00133</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Haemorrhoids; anal fissures; controlled clinical trial.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhoids</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984641
  org study id: CONAN2019
  nct id: NCT05984641
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological
        Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of
        haemorrhoidal disease and anal fissures.
  Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin
        and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its
        potential efficacy in reducing related symptoms.
  
        Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them,
        20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the
        untreated control group (Group B). At each scheduled visit, total symptoms were assessed and
        recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events
        reported by study subjects were also assessed and recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in the symptom numerical rating scale
  time frame: 30 days
  description: The primary outcome was the change in the symptom numerical rating scale (NRS) score after one month (V3) of treatment compared to the baseline in the two groups.
  measure: Safety and Treatment compliance
  time frame: 30 days
  description: The safety of the treatment was investigated by recording and systemic and local adverse events such as systemic allergic reactions, skin sensitisation and discomfort, etc. Treatment compliance was evaluated through assessment by the investigator of the empty study treatment cream tubes returned by patients at the end of the study.
  arm group label: Group A
  arm group type: Experimental
  description: Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
  arm group label: Group B
  arm group type: No Intervention
  description: No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
  intervention type: Device
  intervention name: CONAN® Proctological Cream
  description: The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.
  arm group label: Group A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Gabriella Giarratano
  role: Principal Investigator
  affiliation: Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Hemorrhoids
  mesh term: Inflammation
  sharing ipd: No