<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/NCT03263273</url>
  </required_header>
  <id_info>
    <org_study_id>HY01-003</org_study_id>
    <nct_id>NCT03263273</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 1% and 3% Topical MIinocycline Gel (HY01) in Patients With Papulopustular Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hovione Scientia Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hovione Scientia Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed&#xD;
      by the change in inflammatory lesion count from baseline over the 12-week treatment period in&#xD;
      patients with moderate-to-severe papulopustular rosacea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Lesion Count</measure>
    <time_frame>12 weeks</time_frame>
    <description>Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline in patients with moderate-to-severe papulopustular rosacea</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator's Global Assessment (IGA) Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, in improving the Investigator's Global Assessment (IGA) scores from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea as defined as either a 2 point improvement from baseline or an improvement to &quot;clear&quot; or &quot;almost clear&quot; on the IGA</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Rosacea</condition>
  <condition>Papulopustular Rosacea</condition>
  <arm_group>
    <arm_group_label>Topical Vehicle Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1% Topical Minocycline Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3% Topical Minocycline Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Topical Minocycline Gel</intervention_name>
    <description>Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention</description>
    <arm_group_label>1% Topical Minocycline Gel</arm_group_label>
    <other_name>HY01 Topical Gel, 1%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3% Topical Minocycline Gel</intervention_name>
    <description>Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention</description>
    <arm_group_label>3% Topical Minocycline Gel</arm_group_label>
    <other_name>HY01 Topical Gel, 3%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Topical Vehicle Gel</intervention_name>
    <description>Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention</description>
    <arm_group_label>Topical Vehicle Gel</arm_group_label>
    <other_name>HY01 Topical Gel, 0%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who had provided written informed consent to participate in the study.&#xD;
&#xD;
          -  Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to&#xD;
             severe facial rosacea, defined as the presence of: i. At least twelve and not more&#xD;
             than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with&#xD;
             a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii.&#xD;
             Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND&#xD;
             iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.&#xD;
&#xD;
          -  Subject willing to minimize external factors that might trigger rosacea flare-ups as&#xD;
             recommended per protocol and patient instructional guide (e.g., spicy foods, thermally&#xD;
             hot foods and drinks, hot environments, prolonged sun exposure, strong winds and&#xD;
             alcoholic beverages).&#xD;
&#xD;
          -  Non-nursing, female subjects of child bearing potential, who are using an acceptable&#xD;
             form of birth control: total abstinence, oral (birth control pills), intravaginal:&#xD;
             (e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or&#xD;
             transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD);&#xD;
             double-barrier (diaphragm or condom with spermicidal gel or foam); for two months&#xD;
             prior to study enrollment or a vasectomized partner. All female subjects of child&#xD;
             bearing potential must have undergone an in-office urine pregnancy test, with a&#xD;
             negative result, prior to being randomized to receive study drug. In addition, women&#xD;
             of childbearing potential must have agreed to a have urine pregnancy test at Day 42&#xD;
             and at the end of the study (Day 84). Females not of childbearing potential due to&#xD;
             menopause must have been postmenopausal for at least one year. Male subjects must be&#xD;
             willing to not attempt to conceive a child during the participation in the study.&#xD;
             Females utilizing oral contraception must be willing to utilize an appropriate&#xD;
             secondary form of contraception during the study.&#xD;
&#xD;
          -  Subjects who use the same brand of soap, make-up, hair products, or shaving&#xD;
             lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit&#xD;
             and agree not to change these product brand/types during the study, with the exception&#xD;
             of using the study approved cleanser and moisturizer with sunscreen provided by the&#xD;
             sponsor.&#xD;
&#xD;
          -  Male subjects who are willing to shave, if applicable, at approximately the same time&#xD;
             every day.&#xD;
&#xD;
          -  Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or&#xD;
             excessive exposure to the sun for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any skin condition on the face that would interfere with the diagnosis or&#xD;
             assessment of rosacea as determined by the Investigator.&#xD;
&#xD;
          -  Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere&#xD;
             with diagnosis or assessment of rosacea. Patients also must not grow excess facial&#xD;
             hair during the study (i.e. they need to be free of excess facial hair for follow-up&#xD;
             visits).&#xD;
&#xD;
          -  History of hypersensitivity or allergy to minocycline, any other tetracycline or any&#xD;
             other component of the formulation, or known reactions to cleansers, including Ponds&#xD;
             Cold Cream, and moisturizer with sunscreen.&#xD;
&#xD;
          -  Subjects using, or planning use of concomitant treatments within 30 days prior to&#xD;
             Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery,&#xD;
             intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray,&#xD;
             IPL, laser therapy or UV therapy).&#xD;
&#xD;
          -  Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin)&#xD;
             or therapeutic vitamin A supplements of greater than 10,000 International Units/day&#xD;
             (multivitamins are allowed).&#xD;
&#xD;
          -  Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol,&#xD;
             Depogen, birth control pills), for less than 2 months prior to the Baseline Visit.&#xD;
             (Subjects using estrogens for 2 months or more are not excluded unless the subject&#xD;
             expected to change dose, drug, or discontinue estrogen use during the study).&#xD;
&#xD;
          -  Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2)&#xD;
             systemic antibiotics known to have an impact on the severity of facial rosacea (e.g.,&#xD;
             containing tetracycline and its derivatives, erythromycin and its derivatives,&#xD;
             sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids.&#xD;
&#xD;
          -  Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2)&#xD;
             topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole,&#xD;
             azelaic acid, erythromycin, ivermectin, sulfur based topical products).&#xD;
&#xD;
          -  Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than&#xD;
             5 nodules or sinus tracts.&#xD;
&#xD;
          -  Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient&#xD;
             severity to require topical or systemic antibiotics.&#xD;
&#xD;
          -  Subjects with underlying diseases or other dermatological conditions, such as; atopic&#xD;
             dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of&#xD;
             interfering topical or systemic therapy or may have interfered with the rosacea&#xD;
             diagnosis.&#xD;
&#xD;
          -  Subjects using an investigational drug or participating in an investigational study&#xD;
             within 30 days of the Baseline Visit. Use of an investigational drug and/or&#xD;
             participation in another investigational study prohibited during this study.&#xD;
&#xD;
          -  Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol&#xD;
             or drug abuse with in the past year.&#xD;
&#xD;
          -  Medical history of immunodeficiency or other significant ongoing medical condition or&#xD;
             disease as determined by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sunil S Dhawan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Dermatology Clinical Research, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Site - 15</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 20</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology Clinical Research, Inc.</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 19</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 5</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 16</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 22</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 23</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 14</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 6</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 12</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 21</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 13</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 2</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 4</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 17</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 11</name>
      <address>
        <city>Fort Washington</city>
        <state>Pennsylvania</state>
        <zip>19034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 8</name>
      <address>
        <city>Goodlettsville</city>
        <state>Tennessee</state>
        <zip>37072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 7</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 18</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 3</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 9</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site - 10</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <disposition_first_submitted>November 1, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>November 1, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 7, 2019</disposition_first_posted>
  <last_update_submitted>November 6, 2019</last_update_submitted>
  <last_update_submitted_qc>November 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Minocycline</keyword>
  <keyword>Topical</keyword>
  <keyword>Tetracycline</keyword>
  <keyword>Doxycycline</keyword>
  <keyword>Rosacea</keyword>
  <keyword>Skin Disease</keyword>
  <keyword>Anti-Bacterial Agent</keyword>
  <keyword>Anti-Inflammatory Agent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03263273
org study id: HY01-003
nct id: NCT03263273
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed
      by the change in inflammatory lesion count from baseline over the 12-week treatment period in
      patients with moderate-to-severe papulopustular rosacea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Lesion Count
time frame: 12 weeks
description: Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline in patients with moderate-to-severe papulopustular rosacea
measure: Investigator's Global Assessment (IGA) Score
time frame: 12 weeks
description: Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, in improving the Investigator's Global Assessment (IGA) scores from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea as defined as either a 2 point improvement from baseline or an improvement to "clear" or "almost clear" on the IGA
arm group label: Topical Vehicle Gel
arm group type: Placebo Comparator
description: Topical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face
arm group label: 1% Topical Minocycline Gel
arm group type: Active Comparator
description: Topical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face
arm group label: 3% Topical Minocycline Gel
arm group type: Active Comparator
description: Topical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face
intervention type: Drug
intervention name: 1% Topical Minocycline Gel
description: Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
arm group label: 1% Topical Minocycline Gel
other name: HY01 Topical Gel, 1%
intervention type: Drug
intervention name: 3% Topical Minocycline Gel
description: Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
arm group label: 3% Topical Minocycline Gel
other name: HY01 Topical Gel, 3%
intervention type: Other
intervention name: Topical Vehicle Gel
description: Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention
arm group label: Topical Vehicle Gel
other name: HY01 Topical Gel, 0%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sunil S Dhawan, MD
role: Principal Investigator
affiliation: Center for Dermatology Clinical Research, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Minocycline
sharing ipd: No