<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/NCT02236403</url>
  </required_header>
  <id_info>
    <org_study_id>demodex0.1</org_study_id>
    <nct_id>NCT02236403</nct_id>
  </id_info>
  <brief_title>Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%</brief_title>
  <official_title>Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Colombia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Colombia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and&#xD;
      Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin&#xD;
      inflammation, so a intervention that reduces the number of mites and bacteria would be&#xD;
      desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice&#xD;
      in humans and in animals and a single application have show a good response in lice&#xD;
      eradication.&#xD;
&#xD;
      In this study , investigators will determinate the security and effectiveness of this&#xD;
      compound in the eradication of mites&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erradication of Demodex mites</measure>
    <time_frame>2 months</time_frame>
    <description>Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score</measure>
    <time_frame>2 months</time_frame>
    <description>Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score&#xD;
None (0) = normal&#xD;
Mild (1) = Slight localized injection&#xD;
Moderate (2) = pink color&#xD;
Severe (3) = dark redness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Blepharitis</condition>
  <arm_group>
    <arm_group_label>Ivermectin 0.1% Metronidazole 1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin 0.1% Metronidazole 1%</intervention_name>
    <arm_group_label>Ivermectin 0.1% Metronidazole 1%</arm_group_label>
    <other_name>22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None intervention</intervention_name>
    <description>Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.&#xD;
&#xD;
               -  Age range: 18 yeras and older.&#xD;
&#xD;
               -  Both genders and all ethnic groups comparable with the local community.&#xD;
&#xD;
               -  Able to understand and willing to sign a written informed consent&#xD;
&#xD;
               -  Able and willing to cooperate with the investigational plan.&#xD;
&#xD;
               -  Able and willing to complete all mandatory follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients who are currently engaged in another clinical trial, unwilling or unable to&#xD;
             give consent, to accept randomization, or to return for scheduled visits.&#xD;
&#xD;
               -  Children under 18.&#xD;
&#xD;
               -  Pregnant women or expecting to be pregnant during the study.&#xD;
&#xD;
               -  Systemic immune deficient conditions such as AIDS or under systemic&#xD;
                  immunosuppressant.&#xD;
&#xD;
               -  Concomitant use of ophthalmic topical medications (excluding non-preserved tear&#xD;
                  substitutes).&#xD;
&#xD;
               -  Concomitant use of systemic antibiotics or steroids.&#xD;
&#xD;
               -  Contact lens wear&#xD;
&#xD;
               -  Active ocular infection or allergy&#xD;
&#xD;
               -  Unable to close eyes or uncontrolled blinking Previous allergic reaction to&#xD;
                  metronidazole and / or ivermectin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Engativa</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blepharitis , Demodex, Ivermectin, Metronidazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Ivermectin</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/NCT02236403
org study id: demodex0.1
nct id: NCT02236403
lead sponsor: 
has dmc: Yes
Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and
      Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin
      inflammation, so a intervention that reduces the number of mites and bacteria would be
      desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice
      in humans and in animals and a single application have show a good response in lice
      eradication.

      In this study , investigators will determinate the security and effectiveness of this
      compound in the eradication of mites
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Erradication of Demodex mites
time frame: 2 months
description: Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication
measure: Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score
time frame: 2 months
description: Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score
None (0) = normal
Mild (1) = Slight localized injection
Moderate (2) = pink color
Severe (3) = dark redness
arm group label: Ivermectin 0.1% Metronidazole 1%
arm group type: Experimental
description: 30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs.
arm group label: Control
arm group type: Placebo Comparator
description: 30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group
intervention type: Drug
intervention name: Ivermectin 0.1% Metronidazole 1%
arm group label: Ivermectin 0.1% Metronidazole 1%
other name: 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b
intervention type: Other
intervention name: None intervention
description: Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: Blepharitis
mesh term: Metronidazole
mesh term: Ivermectin