<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/NCT03787030</url>
  </required_header>
  <id_info>
    <org_study_id>Garcia 2018-12</org_study_id>
    <nct_id>NCT03787030</nct_id>
  </id_info>
  <brief_title>Application of Vitamin E on Anal Fissure</brief_title>
  <official_title>Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients were randomized into 2 groups:&#xD;
&#xD;
        -  Vitamin E: Vitamin E ointment will be applied during 8 weeks&#xD;
&#xD;
        -  Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks&#xD;
&#xD;
      Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and&#xD;
      subjects patients receiving Vitamin E ointment were evaluated .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomly assigned to experimental and control groups: those patients receiving&#xD;
      vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment&#xD;
      (Control Group - CG).&#xD;
&#xD;
      Treatments:&#xD;
&#xD;
      Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4&#xD;
      glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased&#xD;
      from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of&#xD;
      glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours&#xD;
      for an 8-week period.&#xD;
&#xD;
      Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE&#xD;
      acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage&#xD;
      for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12&#xD;
      hours for an 8-week period.&#xD;
&#xD;
      Healing rate of chronic anal fissure was investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain associated to anal fissure: Visual Analogic Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants achieving the healing of the fissure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Healing, defined as evidence of fissure reepithelization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Vitamin E acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glyceryl trinitrate ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin E Acetate ointment</intervention_name>
    <description>Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.</description>
    <arm_group_label>Vitamin E acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyceryl trinitrate ointment</intervention_name>
    <description>Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.</description>
    <arm_group_label>Glyceryl trinitrate ointment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of chronic anal fissure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with associated anal pathologies&#xD;
&#xD;
          -  intestinal inflammation disorders&#xD;
&#xD;
          -  immunosuppression&#xD;
&#xD;
          -  fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually&#xD;
             transmitted diseases)&#xD;
&#xD;
          -  patients with a history of headaches, heart disease, or intolerance to nitrates&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  patients with closed angle glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina Llavero</last_name>
    <role>Study Director</role>
    <affiliation>Garcilaso Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Garcilaso Clinic</name>
      <address>
        <city>Madrid</city>
        <zip>28010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Department of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fissure in Ano</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>Tocopherols</mesh_term>
    <mesh_term>alpha-Tocopherol</mesh_term>
    <mesh_term>Nitroglycerin</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/NCT03787030
org study id: Garcia 2018-12
nct id: NCT03787030
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients were randomized into 2 groups:

        -  Vitamin E: Vitamin E ointment will be applied during 8 weeks

        -  Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks

      Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and
      subjects patients receiving Vitamin E ointment were evaluated .
Patients were randomly assigned to experimental and control groups: those patients receiving
      vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment
      (Control Group - CG).

      Treatments:

      Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4
      glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased
      from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of
      glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours
      for an 8-week period.

      Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE
      acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage
      for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12
      hours for an 8-week period.

      Healing rate of chronic anal fissure was investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
measure: Pain associated to anal fissure: Visual Analogic Scale
time frame: 8 weeks
description: Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)
measure: Number of participants achieving the healing of the fissure
time frame: 8 weeks
description: Healing, defined as evidence of fissure reepithelization
arm group label: Vitamin E acetate
arm group type: Experimental
description: Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
arm group label: Glyceryl trinitrate ointment
arm group type: Active Comparator
description: Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
intervention type: Drug
intervention name: Vitamin E Acetate ointment
description: Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
arm group label: Vitamin E acetate
intervention type: Drug
intervention name: Glyceryl trinitrate ointment
description: Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
arm group label: Glyceryl trinitrate ointment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carolina Llavero
role: Study Director
affiliation: Garcilaso Clinic
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Department of Surgery
mesh term: Fissure in Ano
mesh term: Vitamin E
mesh term: Tocopherols
mesh term: alpha-Tocopherol
mesh term: Nitroglycerin