<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/NCT03756389</url>
  </required_header>
  <id_info>
    <org_study_id>BMX-DERM-202</org_study_id>
    <nct_id>NCT03756389</nct_id>
  </id_info>
  <brief_title>Evaluation of Topical Application of BMX-010 in Subjects With Rosacea</brief_title>
  <official_title>An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioMimetix JV, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioMimetix JV, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be&#xD;
      conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the&#xD;
      study drug. Up to 60 subjects will be enrolled in this part.&#xD;
&#xD;
      Part B is designed to be a randomized, double-blind trial studying the optimal formulation,&#xD;
      strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo. Up to&#xD;
      150 subjects will be enrolled in this part.&#xD;
&#xD;
      In both parts, adult subjects with Rosacea will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Re-formulation of study product&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>In Part A, all subjects will receive study drug and this is Open Label. When Part A is complete, Part B will start and this will be double blind to participant and investigators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if BMX-010 cream or gel provides better efficacy in the treatment of rosacea.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if BMX-010 cream or gel provides better efficacy in the treatment of the redness of rosacea.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the efficacy of BMX-010 in treatment of rosacea.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the effect of BMX-010 on redness in patients with rosacea.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Document, as possible, the clinical effects of BMX-010 in subjects with Rosacea through clinical photography.</measure>
    <time_frame>43 days</time_frame>
    <description>If consented by the patient, photos will be taken at each study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the mean percent reduction change in inflammatory papules/pustules counts from baseline to end of study.</measure>
    <time_frame>43 days</time_frame>
    <description>Inflammatory lesions will be counted at each study visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>BMX-010 0.03%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMX-010 0.1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMX-010</intervention_name>
    <description>Safety and efficacy of BMX-010 in topical treatment of rosacea.</description>
    <arm_group_label>BMX-010 0.03%</arm_group_label>
    <arm_group_label>BMX-010 0.1%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, at least 18 years of age;&#xD;
&#xD;
          2. A clinical diagnosis of mild to severe facial rosacea;&#xD;
&#xD;
          3. Screening and Baseline IGA score &gt; 2 (greater than or equal to 2);&#xD;
&#xD;
          4. A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline&#xD;
             Visits (prior to the investigational product application);&#xD;
&#xD;
          5. Willing to refrain from using any topical or systemic treatments for inflammatory skin&#xD;
             disease, other than the investigational product;&#xD;
&#xD;
          6. Candidate for topical treatment of Rosacea;&#xD;
&#xD;
          7. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be&#xD;
             willing to use only allowed cleansers, moisturizers, sunscreens, or&#xD;
             moisturizer/sunscreen combination products. If the subject wears makeup they must&#xD;
             agree to use non-comedogenic makeup;&#xD;
&#xD;
          8. Females of child-bearing potential must have a negative urine pregnancy test within 48&#xD;
             hours prior to the first drug administration;&#xD;
&#xD;
          9. Females of child-bearing potential must be willing to use 2 methods of contraception&#xD;
             deemed adequate by the investigator (for example, oral contraceptive pills plus a&#xD;
             barrier method) through the trial and for 1 month thereafter to be eligible for, and&#xD;
             continue participation in, the study;&#xD;
&#xD;
         10. Ability to complete the study in compliance with the protocol, including agreement in&#xD;
             writing to apply study product only to the assigned areas; and&#xD;
&#xD;
         11. Ability to understand and provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any dermatological conditions on the face that could interfere with clinical&#xD;
             evaluations;&#xD;
&#xD;
          2. Any underlying disease(s) or some other dermatological condition of the face that&#xD;
             requires the use of interfering topical or systemic therapy or makes evaluations and&#xD;
             lesion count inconclusive;&#xD;
&#xD;
          3. Presence of beard or excessive facial hair at Screening which would interfere with the&#xD;
             study treatments or study assessments and refusal to remove for duration of study;&#xD;
&#xD;
          4. Subjects with any underlying disease that the Investigator deems uncontrolled, and&#xD;
             poses a concern for the subject's safety while participating in the study;&#xD;
&#xD;
          5. Concomitant skin disease that could confound clinical evaluations or increase risk to&#xD;
             the subject;&#xD;
&#xD;
          6. Use of medicated make-up (including anti-aging make-up) throughout the study;&#xD;
&#xD;
          7. Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3)&#xD;
             antibiotics known to impact rosacea, 4) immunosuppressive agents, or immunomodulators;&#xD;
&#xD;
          8. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical&#xD;
             antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics;&#xD;
&#xD;
          9. Use of medicated cleansers on the face (throughout the study);&#xD;
&#xD;
         10. Use of topical astringents or abrasives, medical topical preparations (prescription&#xD;
             and OTC products) within 2 days prior to Baseline and throughout the study;&#xD;
&#xD;
         11. Systemic or skin infection requiring antimicrobial therapy;&#xD;
&#xD;
         12. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;&#xD;
&#xD;
         13. Immunocompromise of any cause, known human immunodeficiency virus infection, or&#xD;
             acquired immunodeficiency syndrome;&#xD;
&#xD;
         14. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the&#xD;
             investigator;&#xD;
&#xD;
         15. Active drug or alcohol dependence;&#xD;
&#xD;
         16. Significant acute or chronic medical, neurological, or psychiatric illness that, in&#xD;
             the judgment of the investigator, could compromise subject safety, limit the subject's&#xD;
             ability to complete the study, and/or compromise the objectives of the study;&#xD;
&#xD;
         17. Previous clinical trial participation for the indication being treated in this&#xD;
             protocol.&#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>Colorado Skin Care</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_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/NCT03756389
org study id: BMX-DERM-202
nct id: NCT03756389
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be
      conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the
      study drug. Up to 60 subjects will be enrolled in this part.

      Part B is designed to be a randomized, double-blind trial studying the optimal formulation,
      strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo. Up to
      150 subjects will be enrolled in this part.

      In both parts, adult subjects with Rosacea will be enrolled.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: In Part A, all subjects will receive study drug and this is Open Label. When Part A is complete, Part B will start and this will be double blind to participant and investigators.
measure: Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.
time frame: 28 days
description: Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.
measure: Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days.
time frame: 28 days
description: Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.
measure: Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days.
time frame: 28 days
description: Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.
measure: Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days.
time frame: 28 days
description: Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.
measure: Determine if BMX-010 cream or gel provides better efficacy in the treatment of rosacea.
time frame: 43 days
description: Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
measure: Determine if BMX-010 cream or gel provides better efficacy in the treatment of the redness of rosacea.
time frame: 43 days
description: Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
measure: Evaluate the efficacy of BMX-010 in treatment of rosacea.
time frame: 43 days
description: Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
measure: Evaluate the effect of BMX-010 on redness in patients with rosacea.
time frame: 43 days
description: Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).
measure: Document, as possible, the clinical effects of BMX-010 in subjects with Rosacea through clinical photography.
time frame: 43 days
description: If consented by the patient, photos will be taken at each study visit.
measure: Assess the mean percent reduction change in inflammatory papules/pustules counts from baseline to end of study.
time frame: 43 days
description: Inflammatory lesions will be counted at each study visit.
arm group label: BMX-010 0.03%
arm group type: Experimental
description: Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face.
arm group label: BMX-010 0.1%
arm group type: Experimental
description: Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face.
intervention type: Drug
intervention name: BMX-010
description: Safety and efficacy of BMX-010 in topical treatment of rosacea.
arm group label: BMX-010 0.03%
arm group label: BMX-010 0.1%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea