<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/NCT03003104</url>
  </required_header>
  <id_info>
    <org_study_id>DMT210-003</org_study_id>
    <nct_id>NCT03003104</nct_id>
  </id_info>
  <brief_title>DMT210 Topical Gel in the Treatment of Acne Rosacea</brief_title>
  <official_title>A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dermata Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dermata Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied&#xD;
      twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of&#xD;
      participants will receive DMT210 Gel while the other half will receive vehicle control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy as measured by Inflammatory lesion counts</measure>
    <time_frame>12 weeks</time_frame>
    <description>Inflammatory lesion counts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as measured by Investigator Global Assessment (IGA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigator Global Assessment (IGA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>5-point Clinical Erythema Assessment (CEA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>5-point Patient Severity Assessment of Erythema (PSA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events as a measure of safety and tolerability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence of adverse events as a measure of safety and tolerability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Acne Rosacea</condition>
  <arm_group>
    <arm_group_label>DMT210 Topical Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical Gel vehicle applied to the face twice daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DMT210 Topical Gel 5%</intervention_name>
    <arm_group_label>DMT210 Topical Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle Control</intervention_name>
    <arm_group_label>Vehicle Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or non-pregnant female at least 18 years of age.&#xD;
&#xD;
          -  Clinical diagnosis of moderate to severe facial rosacea as determined by&#xD;
             Investigator's Global Assessment (IGA) at Randomization&#xD;
&#xD;
          -  Patient has at least ten inflammatory lesions of rosacea on the face at Randomization&#xD;
&#xD;
          -  Patient is willing to apply the Investigational Product as directed&#xD;
&#xD;
          -  Patient is willing and able to comply with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant or planning to become pregnant&#xD;
&#xD;
          -  Patient is taking a topical therapy which may affect the patient's rosacea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Broomall</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermata Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin diseases</keyword>
  <keyword>rosacea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03003104
org study id: DMT210-003
nct id: NCT03003104
lead sponsor: 
has dmc: No
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied
      twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of
      participants will receive DMT210 Gel while the other half will receive vehicle control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Efficacy as measured by Inflammatory lesion counts
time frame: 12 weeks
description: Inflammatory lesion counts
measure: Efficacy as measured by Investigator Global Assessment (IGA)
time frame: 12 weeks
description: Investigator Global Assessment (IGA)
measure: Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
time frame: 12 weeks
description: 5-point Clinical Erythema Assessment (CEA)
measure: Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
time frame: 12 weeks
description: 5-point Patient Severity Assessment of Erythema (PSA)
measure: Incidence of adverse events as a measure of safety and tolerability
time frame: 12 weeks
description: Incidence of adverse events as a measure of safety and tolerability
arm group label: DMT210 Topical Gel
arm group type: Experimental
description: DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
arm group label: Vehicle Control
arm group type: Placebo Comparator
description: Topical Gel vehicle applied to the face twice daily for 12 weeks
intervention type: Drug
intervention name: DMT210 Topical Gel 5%
arm group label: DMT210 Topical Gel
intervention type: Other
intervention name: Vehicle Control
arm group label: Vehicle Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
sharing ipd: No