<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/NCT03307577</url>
  </required_header>
  <id_info>
    <org_study_id>000-8651-202</org_study_id>
    <nct_id>NCT03307577</nct_id>
  </id_info>
  <brief_title>A Phase 2 Safety and Efficacy Study of UHE-101 Cream in Subjects With Acne Vulgaris</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of UHE-101 Cream 1% When Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Therapeutics, Inc.</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>
      UHE-101 cream, 1% (&quot;UHE-101&quot;) is being developed for the topical treatment of acne vulgaris.&#xD;
      The purpose of this study is to compare the safety and efficacy of twice daily topical&#xD;
      application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne&#xD;
      vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active&#xD;
      drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne.&#xD;
&#xD;
      Patients who qualify for this study will apply the study cream twice daily (once in the&#xD;
      morning and once in the evening) for 12 weeks.&#xD;
&#xD;
      Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle&#xD;
      cream that does not include an active drug (i.e., placebo). This is a double-blind study,&#xD;
      which means that neither the patient nor the investigator will know which cream the patient&#xD;
      is using. The study will last about 12 weeks and will involve 5 clinic visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator's Global Assessment (IGA) &quot;Success&quot;</measure>
    <time_frame>Week 12</time_frame>
    <description>Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of &quot;clear&quot; or &quot;almost clear&quot; (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acne Lesion Counts (Absolute Change)</measure>
    <time_frame>Week 12</time_frame>
    <description>Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IGA &quot;Success&quot;</measure>
    <time_frame>Week 4</time_frame>
    <description>Proportion of subjects achieving success in each treatment group at Week 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGA &quot;Success&quot;</measure>
    <time_frame>Week 8</time_frame>
    <description>Proportion of subjects achieving success in each treatment group at Week 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acne Lesion Counts (Absolute Change)</measure>
    <time_frame>Week 4</time_frame>
    <description>Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acne Lesion Counts (Absolute Change)</measure>
    <time_frame>Week 8</time_frame>
    <description>Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acne Lesion Counts (Percent Change)</measure>
    <time_frame>Week 4</time_frame>
    <description>Percent change from Baseline in lesion counts in each treatment group at Week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acne Lesion Counts (Percent Change)</measure>
    <time_frame>Week 8</time_frame>
    <description>Percent change from Baseline in lesion counts in each treatment group at Week 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acne Lesion Counts (Percent Change)</measure>
    <time_frame>Week 12</time_frame>
    <description>Percent change from Baseline in lesion counts in each treatment group at Week 12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>UHE-101 cream, 1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cream is applied twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cream is applied twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UHE-101 Cream</intervention_name>
    <description>Topical cream containing investigational drug at a concentration of 1%</description>
    <arm_group_label>UHE-101 cream, 1%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle Cream</intervention_name>
    <description>Topical cream containing no drug (i.e., placebo)</description>
    <arm_group_label>Vehicle cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must provide written informed consent/assent. A patient under 18 years of age&#xD;
             must provide written informed assent and be accompanied by the parent or legal&#xD;
             guardian at the time of assent/consent signing. The parent or legal guardian must&#xD;
             provide informed consent for the patient. If a patient becomes 18 years of age during&#xD;
             the study, the patient must provide written informed consent at that time to continue&#xD;
             study participation.&#xD;
&#xD;
          2. Females must be post-menopausal, surgically sterile, or use an effective method of&#xD;
             birth control.&#xD;
&#xD;
          3. Patient has moderate to severe facial acne vulgaris.&#xD;
&#xD;
          4. Patient must be in good general health as determined by the investigator and supported&#xD;
             by medical history, physical and Vital Signs exam.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating, or are planning to become pregnant during the&#xD;
             study.&#xD;
&#xD;
          2. Patient has active nodulocystic acne or acne conglobate, acne fulminans, or other&#xD;
             forms of acne (e.g., acne mechanica).&#xD;
&#xD;
          3. Patient has any skin pathology or condition that, in the investigator's opinion, could&#xD;
             interfere with the evaluation of the test article or requires use of interfering&#xD;
             topical, systemic, or surgical therapy.&#xD;
&#xD;
          4. Patient has used any of the following topical anti-acne preparations or procedures on&#xD;
             the face:&#xD;
&#xD;
               -  Topical anti-acne treatments including, but not limited to, over the-counter&#xD;
                  (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid,&#xD;
                  dapsone, sulfa based products, corticosteroids, and salicylic acid within two&#xD;
                  weeks of Baseline;&#xD;
&#xD;
               -  Topical retinoids (e.g., tazarotene, adapalene, and tretinoin) within four weeks&#xD;
                  of Baseline;&#xD;
&#xD;
               -  Light treatments, microdermabrasion, or chemical peels within eight weeks of&#xD;
                  Baseline;&#xD;
&#xD;
               -  Other topical therapy, which may materially affect the patient's acne, in the&#xD;
                  investigator's opinion.&#xD;
&#xD;
          5. Patient has used any of the following systemic anti-acne medications:&#xD;
&#xD;
               -  Corticosteroids (including intramuscular and intralesional injections) within&#xD;
                  four weeks of Baseline. Inhaled, intranasal, or ocular corticosteroids are&#xD;
                  allowed if use is stable;&#xD;
&#xD;
               -  Antibiotics or other systemic anti-acne medications within four weeks of&#xD;
                  Baseline, with the exception of five days or less of antibiotic therapy during&#xD;
                  this period, but not within one week of Baseline;&#xD;
&#xD;
               -  Androgen receptor blockers (i.e., spironolactone or flutamide) within eight weeks&#xD;
                  of Baseline; with the exception of five days or less of spironolactone therapy&#xD;
                  during this period, but not within one week of Baseline;&#xD;
&#xD;
               -  Retinoid therapy (e.g., isotretinoin) within six months of Baseline;&#xD;
&#xD;
               -  Vitamin A supplements (greater than 10,000 units per day) within six months of&#xD;
                  Baseline;&#xD;
&#xD;
               -  Other systemic therapy, which may materially affect the patient's acne, in the&#xD;
                  investigator's opinion.&#xD;
&#xD;
          6. Patient has the need or plans to be exposed to artificial tanning devices or excessive&#xD;
             sunlight during the study.&#xD;
&#xD;
          7. Patient has used an investigational drug or investigational device treatment within 30&#xD;
             days prior to first application of the test article or is currently enrolled in an&#xD;
             investigational drug, device, or biologic study.&#xD;
&#xD;
          8. Patient has a history of sensitivity to any of the ingredients in the test articles.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <disposition_first_submitted>May 17, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>May 17, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 24, 2019</disposition_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03307577
org study id: 000-8651-202
nct id: NCT03307577
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris.
      The purpose of this study is to compare the safety and efficacy of twice daily topical
      application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne
      vulgaris.
The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active
      drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne.

      Patients who qualify for this study will apply the study cream twice daily (once in the
      morning and once in the evening) for 12 weeks.

      Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle
      cream that does not include an active drug (i.e., placebo). This is a double-blind study,
      which means that neither the patient nor the investigator will know which cream the patient
      is using. The study will last about 12 weeks and will involve 5 clinic visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using.
measure: Investigator's Global Assessment (IGA) "Success"
time frame: Week 12
description: Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.
measure: Acne Lesion Counts (Absolute Change)
time frame: Week 12
description: Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.
measure: IGA "Success"
time frame: Week 4
description: Proportion of subjects achieving success in each treatment group at Week 4.
measure: IGA "Success"
time frame: Week 8
description: Proportion of subjects achieving success in each treatment group at Week 8.
measure: Acne Lesion Counts (Absolute Change)
time frame: Week 4
description: Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 4.
measure: Acne Lesion Counts (Absolute Change)
time frame: Week 8
description: Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 8.
measure: Acne Lesion Counts (Percent Change)
time frame: Week 4
description: Percent change from Baseline in lesion counts in each treatment group at Week 4
measure: Acne Lesion Counts (Percent Change)
time frame: Week 8
description: Percent change from Baseline in lesion counts in each treatment group at Week 8
measure: Acne Lesion Counts (Percent Change)
time frame: Week 12
description: Percent change from Baseline in lesion counts in each treatment group at Week 12
arm group label: UHE-101 cream, 1%
arm group type: Experimental
description: Cream is applied twice a day
arm group label: Vehicle cream
arm group type: Placebo Comparator
description: Cream is applied twice a day
intervention type: Drug
intervention name: UHE-101 Cream
description: Topical cream containing investigational drug at a concentration of 1%
arm group label: UHE-101 cream, 1%
intervention type: Other
intervention name: Vehicle Cream
description: Topical cream containing no drug (i.e., placebo)
arm group label: Vehicle cream
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris