xml: <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/NCT06024499</url>
    </required_header>
    <id_info>
      <org_study_id>HY209-AD-02</org_study_id>
      <nct_id>NCT06024499</nct_id>
    </id_info>
    <brief_title>Phase 2 Trial of HY209gel in Atopic Dermatitis Patients</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shaperon</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shaperon</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in&#xD;
        patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Part 1 (2 cohorts): Total 33 subjects&#xD;
  &#xD;
          -  Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo)&#xD;
  &#xD;
          -  Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo)&#xD;
  &#xD;
          -  Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo)&#xD;
  &#xD;
        Part 2 (3 treatment groups): Total 177 subjects&#xD;
  &#xD;
          -  Low dose of HY209gel: 59 subjects&#xD;
  &#xD;
          -  High dose of HY209gel: 59 subjects&#xD;
  &#xD;
          -  Placebo (Vehicle): 59 subjects&#xD;
  &#xD;
        Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with&#xD;
        escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and&#xD;
        tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the&#xD;
        Safety Monitoring Committee(SMC) that will review all available safety data of the planned&#xD;
        dose level within the timeline specified on SMC charter after all enrolled subjects of each&#xD;
        cohort complete 2-week treatment and determine the escalation to the next dose to be safe.&#xD;
  &#xD;
        Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two&#xD;
        doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment&#xD;
        arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel,&#xD;
        compared to placebo (vehicle) for 8-week treatment period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 31, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>A Randomized, Double-blind, Placebo-controlled Study</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage change in Eczema Area and Severity Index (EASI) score</measure>
      <time_frame>at Week 8</time_frame>
      <description>To achieve lower score means disease improvement .</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Atopic Dermatitis</condition>
    <condition>Atopic Dermatitis Eczema</condition>
    <condition>Atopic Dermatitis of Scalp</condition>
    <arm_group>
      <arm_group_label>PART 2 High-Dose</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Active group selected for PART1 as a high-dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PART 2 Low-Dose</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Active group selected for PART1 as a Low-dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PART 2 Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HY209GEL Active</intervention_name>
      <description>Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1</description>
      <arm_group_label>PART 2 High-Dose</arm_group_label>
      <arm_group_label>PART 2 Low-Dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>PART 2 Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects aged 18 or older&#xD;
  &#xD;
            -  Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria&#xD;
               by a board certified/eligible dermatologist at least 6 months ago from screening&#xD;
  &#xD;
            -  Subjects who have a minimum of 5% and a maximum of 30% of total body surface area&#xD;
               (BSA) affected by AD at screening and baseline visits&#xD;
  &#xD;
            -  Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and&#xD;
               baseline visit&#xD;
  &#xD;
            -  Subjects who can give written informed consent&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or&#xD;
               any consistent requirement for any potency topical corticosteroids&#xD;
  &#xD;
            -  Subjects who have topical treatment with corticosteroids within 2 weeks prior to&#xD;
               baseline visit or other topical treatments of the AD area at screening&#xD;
               (moisturizers/emollients are allowed)&#xD;
  &#xD;
            -  Subjects who had systemic treatment with corticosteroids or cyclosporine or other&#xD;
               immunosuppressive treatments within 4 weeks prior to baseline visit&#xD;
  &#xD;
            -  Subjects who had dupilumab or any other biologics within 6 months prior to baseline&#xD;
               visit&#xD;
  &#xD;
            -  Subjects who take any systemic anti-infective or antibiotic treatments within 1 week&#xD;
               prior to baseline visit&#xD;
  &#xD;
            -  Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks&#xD;
               prior to screening&#xD;
  &#xD;
            -  Subjects who have active malignancy or history of cancer in 5 years prior to&#xD;
               screening, except for treated cautions basal cell carcinoma and in situ cervical&#xD;
               cancer&#xD;
  &#xD;
            -  Subjects who have any other skin diseases that would affect the ability to assess the&#xD;
               AD&#xD;
  &#xD;
            -  Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in&#xD;
               the opinion of the PI, may cause interference with the treatment&#xD;
  &#xD;
            -  Subjects who participated in another drug or device trial within 4 weeks prior to&#xD;
               screening...etc&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024499
  org study id: HY209-AD-02
  nct id: NCT06024499
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in
        patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.
  Part 1 (2 cohorts): Total 33 subjects
  
          -  Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo)
  
          -  Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo)
  
          -  Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo)
  
        Part 2 (3 treatment groups): Total 177 subjects
  
          -  Low dose of HY209gel: 59 subjects
  
          -  High dose of HY209gel: 59 subjects
  
          -  Placebo (Vehicle): 59 subjects
  
        Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with
        escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and
        tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the
        Safety Monitoring Committee(SMC) that will review all available safety data of the planned
        dose level within the timeline specified on SMC charter after all enrolled subjects of each
        cohort complete 2-week treatment and determine the escalation to the next dose to be safe.
  
        Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two
        doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment
        arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel,
        compared to placebo (vehicle) for 8-week treatment period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: A Randomized, Double-blind, Placebo-controlled Study
  measure: Percentage change in Eczema Area and Severity Index (EASI) score
  time frame: at Week 8
  description: To achieve lower score means disease improvement .
  arm group label: PART 2 High-Dose
  arm group type: Active Comparator
  description: Active group selected for PART1 as a high-dose
  arm group label: PART 2 Low-Dose
  arm group type: Active Comparator
  description: Active group selected for PART1 as a Low-dose
  arm group label: PART 2 Placebo
  arm group type: Placebo Comparator
  description: Placebo group
  intervention type: Drug
  intervention name: HY209GEL Active
  description: Selected two among three doses (HY209GEL 0.5% or 1% or 2%) in PART1
  arm group label: PART 2 High-Dose
  arm group label: PART 2 Low-Dose
  intervention type: Other
  intervention name: Placebo
  description: Placebo
  arm group label: PART 2 Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema