<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/NCT03752242</url>
  </required_header>
  <id_info>
    <org_study_id>BMX-DERM-203</org_study_id>
    <nct_id>NCT03752242</nct_id>
  </id_info>
  <brief_title>Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.</brief_title>
  <official_title>An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.</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 Acne Vulgaris which will be&#xD;
      conducted in two parts. Up to 210 subjects with Acne Vulgaris 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 in patients with Acne. 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 in&#xD;
      patients with Acne. Up to 150 subjects will be enrolled in this part. In both parts, adult&#xD;
      subjects with Rosacea will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment stopped for chemistry work on investigational product.&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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 7 to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.</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 7 to 28 days.</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if BMX-010 cream or gel provides better efficacy in the clearing of acne.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the efficacy of BMX-010 in treatment of Acne Vulgaris.</measure>
    <time_frame>43 days</time_frame>
    <description>Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Document, as possible, the clinical effects of BMX-010 in subjects with Acne Vulgaris 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 and noninflammatory lesion counts from baseline to end of study.</measure>
    <time_frame>43 days</time_frame>
    <description>Inflammatory and non-inflammatory lesions will be counted at each study visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Acne Vulgaris</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 Acne 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 Acne 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 acne.</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 Acne Vulgaris; Subjects may also have&#xD;
             acne at other body sites;&#xD;
&#xD;
          3. Screening and Baseline IGA score &gt; 2 (greater than or equal to 2);&#xD;
&#xD;
          4. Willing to refrain from using any topical or systemic treatments for inflammatory skin&#xD;
             disease, other than the investigational product;&#xD;
&#xD;
          5. Candidate for topical treatment of Acne;&#xD;
&#xD;
          6. 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;
          7. Females of child-bearing potential must have a negative urine pregnancy test within 48&#xD;
             hours prior to the first drug administration;&#xD;
&#xD;
          8. 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;
          9. 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;
         10. Ability to understand and provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 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;
          2. Use of androgen receptor blockers (such as spironolactone or flutamide);&#xD;
&#xD;
          3. Severe cystic acne, acne conglobate, acne fulminans, or secondary acne;&#xD;
&#xD;
          4. Use of phototherapy devices, energy-based devices, adhesive cleansing strips, or&#xD;
             cosmetic procedures (e.g., facials, peeling, comedo extraction) in the past week;&#xD;
&#xD;
          5. 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;
          6. Prior or current concomitant therapies that would interfere with assessments in the&#xD;
             study;&#xD;
&#xD;
          7. 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;
          8. Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,&#xD;
             antibacterials (including benzoyl peroxide-containing products [e.g., benzamycin]),&#xD;
             retinoids; other topical acne treatments (e.g., photodynamic therapy, medicated soaps&#xD;
             such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium&#xD;
             sulfacetamide) in the past 2 weeks;&#xD;
&#xD;
          9. Oral retinoid use (e.g., isotretinoin) within 6 months prior to baseline or vitamin A&#xD;
             supplements greater than 10,000 units/day within 6 months of baseline;&#xD;
&#xD;
         10. Concomitant skin disease that could confound clinical evaluations or increase risk to&#xD;
             the subject;&#xD;
&#xD;
         11. Use of medicated make-up (including anti-aging make-up) throughout the study;&#xD;
&#xD;
         12. Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3)&#xD;
             antibiotics known to impact acne, 4) immunosuppressive agents, or immunomodulators;&#xD;
&#xD;
         13. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical&#xD;
             antimycotics, 4) any topical acne treatments or 4) topical antibiotics;&#xD;
&#xD;
         14. Use of medicated cleansers on the face (throughout the study);&#xD;
&#xD;
         15. 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;
         16. Systemic or skin infection requiring antimicrobial therapy;&#xD;
&#xD;
         17. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;&#xD;
&#xD;
         18. Immunocompromise of any cause, known human immunodeficiency virus infection, or&#xD;
             acquired immunodeficiency syndrome;&#xD;
&#xD;
         19. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the&#xD;
             investigator;&#xD;
&#xD;
         20. Active drug or alcohol dependence;&#xD;
&#xD;
         21. 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;
         22. 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>October 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</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>Acne Vulgaris</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 9, 2023</submitted>
    <returned>February 3, 2023</returned>
    <submitted>February 6, 2023</submitted>
    <returned>February 28, 2023</returned>
    <submitted>April 5, 2023</submitted>
    <returned>April 26, 2023</returned>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03752242
org study id: BMX-DERM-203
nct id: NCT03752242
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 Acne Vulgaris which will be
      conducted in two parts. Up to 210 subjects with Acne Vulgaris will be enrolled.
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the
      study drug in patients with Acne. 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 in
      patients with Acne. 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 7 to 28 days.
time frame: 28 days
description: Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
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 7 to 28 days.
time frame: 28 days
description: Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
measure: Determine if BMX-010 cream or gel provides better efficacy in the clearing of acne.
time frame: 43 days
description: Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
measure: Evaluate the efficacy of BMX-010 in treatment of Acne Vulgaris.
time frame: 43 days
description: Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
measure: Document, as possible, the clinical effects of BMX-010 in subjects with Acne Vulgaris 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 and noninflammatory lesion counts from baseline to end of study.
time frame: 43 days
description: Inflammatory and non-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 Acne 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 Acne of the face.
intervention type: Drug
intervention name: BMX-010
description: Safety and efficacy of BMX-010 in topical treatment of acne.
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: Acne Vulgaris
sharing ipd: Undecided
submitted: January 9, 2023
returned: February 3, 2023
submitted: February 6, 2023
returned: February 28, 2023
submitted: April 5, 2023
returned: April 26, 2023
submitted: August 25, 2023