<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/NCT02205892</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH-lupeol</org_study_id>
    <nct_id>NCT02205892</nct_id>
  </id_info>
  <brief_title>Clinical Study for Topical Lupeol in Acne</brief_title>
  <official_title>Clinical Study for the Effectiveness and Safety of Topical Lupeol in Mild to Moderate Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of&#xD;
      inflammatory and non-inflammatory acne lesions in split face fashion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the clinical efficacy and tolerability of lupeol for the treatment of facial&#xD;
      acne, we conducted a small-scale, randomized, double-blinded, split-face clinical trial over&#xD;
      the course of 4 weeks. Fifteen of 16 enrolled patients completed the study, in which affected&#xD;
      areas on half each patient's face were treated with 2% lupeol twice daily while the other&#xD;
      side of the face was treated with a vehicle control. Clinical visits were scheduled at&#xD;
      baseline and at 2 and 4 weeks. The primary outcome of the study was the percent change in&#xD;
      inflammatory lesions (papules, pustules, and nodules) at 4 weeks. The secondary outcomes were&#xD;
      the percent change in non-inflammatory lesions (open and closed comedones) and the change in&#xD;
      the Leeds revised acne grading system score at 4 weeks. Adverse events (AEs) were defined as&#xD;
      all unintended and harmful signs or symptoms; these were assessed by both patients'&#xD;
      self-reporting and physicians' skin examination at each visit. Results were analyzed using&#xD;
      intent to treat (ITT) groups. The per-protocol (PP) population consisted of the 15 patients&#xD;
      who did not have any major protocol deviations. Last observation carried forward (LOCF)&#xD;
      analysis was used to evaluate the primary and secondary outcomes.&#xD;
&#xD;
      ** Randomization and blindness process **&#xD;
&#xD;
      At the time of initial presentation, an evaluation of acne severity was performed using both&#xD;
      individual counts of inflammatory and non-inflammatory acne lesions and an assessment of the&#xD;
      Leeds revised acne grading system score. Then, patients were randomly assigned to either&#xD;
      left- or right-sided lupeol application, with the other side of the face assigned to&#xD;
      vehicle-control application. A simple random allocation sequence was created using&#xD;
      computer-based random number generators with a block size of 4. All dermatologists&#xD;
      participating in outcome assessments, a physician assistant managing trial enrollment and&#xD;
      administration, medical statisticians analyzing the data, and patients were blinded to the&#xD;
      assignments. Randomization codes were strictly secured in a safe in the administration office&#xD;
      of the clinical research center until data entry was complete. The integrity of the blinding&#xD;
      was ensured by packaging the study- and control products in identical tubes and by requiring&#xD;
      a third party (other than the investigator/evaluator) to dispense the medication. In&#xD;
      addition, both topical agents were identical in color and odor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</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>Percent change of inflammatory acne lesion counts</measure>
    <time_frame>4 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change of non-inflammatory acne lesion counts</measure>
    <time_frame>4 week</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Leeds revised grade</measure>
    <time_frame>4 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>Lupeol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lupeol</intervention_name>
    <description>Patients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined.</description>
    <arm_group_label>Lupeol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo vehicle</intervention_name>
    <description>Patients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined.</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients over the age 15 years of age or older who were clinically diagnosed with mild to&#xD;
        moderate acne vulgaris (Leeds revised acne grading system score 2-7)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Known pregnancy or lactation, any medical illness that might influence the results of the&#xD;
        study, a previous history of oral acne medication or surgical procedures including laser&#xD;
        treatment within 6 month and topical medication within 4 weeks of study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dae Hun Suh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Department of Dermatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hyuck Hoon Kwon, MD</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Department of Dermatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sun Yong Park</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Department of Dermatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seounguk Min</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Department of Dermatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jae Yoon Jung</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Department of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Department of Dermatology</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Dae Hun Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>natural product</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupeol</mesh_term>
  </intervention_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/NCT02205892
org study id: SNUH-lupeol
nct id: NCT02205892
lead sponsor: 
has dmc: Yes
Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of
      inflammatory and non-inflammatory acne lesions in split face fashion
To investigate the clinical efficacy and tolerability of lupeol for the treatment of facial
      acne, we conducted a small-scale, randomized, double-blinded, split-face clinical trial over
      the course of 4 weeks. Fifteen of 16 enrolled patients completed the study, in which affected
      areas on half each patient's face were treated with 2% lupeol twice daily while the other
      side of the face was treated with a vehicle control. Clinical visits were scheduled at
      baseline and at 2 and 4 weeks. The primary outcome of the study was the percent change in
      inflammatory lesions (papules, pustules, and nodules) at 4 weeks. The secondary outcomes were
      the percent change in non-inflammatory lesions (open and closed comedones) and the change in
      the Leeds revised acne grading system score at 4 weeks. Adverse events (AEs) were defined as
      all unintended and harmful signs or symptoms; these were assessed by both patients'
      self-reporting and physicians' skin examination at each visit. Results were analyzed using
      intent to treat (ITT) groups. The per-protocol (PP) population consisted of the 15 patients
      who did not have any major protocol deviations. Last observation carried forward (LOCF)
      analysis was used to evaluate the primary and secondary outcomes.

      ** Randomization and blindness process **

      At the time of initial presentation, an evaluation of acne severity was performed using both
      individual counts of inflammatory and non-inflammatory acne lesions and an assessment of the
      Leeds revised acne grading system score. Then, patients were randomly assigned to either
      left- or right-sided lupeol application, with the other side of the face assigned to
      vehicle-control application. A simple random allocation sequence was created using
      computer-based random number generators with a block size of 4. All dermatologists
      participating in outcome assessments, a physician assistant managing trial enrollment and
      administration, medical statisticians analyzing the data, and patients were blinded to the
      assignments. Randomization codes were strictly secured in a safe in the administration office
      of the clinical research center until data entry was complete. The integrity of the blinding
      was ensured by packaging the study- and control products in identical tubes and by requiring
      a third party (other than the investigator/evaluator) to dispense the medication. In
      addition, both topical agents were identical in color and odor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent change of inflammatory acne lesion counts
time frame: 4 week
measure: Percent change of non-inflammatory acne lesion counts
time frame: 4 week
measure: Change of Leeds revised grade
time frame: 4 week
arm group label: Lupeol
arm group type: Active Comparator
arm group label: Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lupeol
description: Patients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined.
arm group label: Lupeol
intervention type: Drug
intervention name: Placebo vehicle
description: Patients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined.
arm group label: Vehicle
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Dae Hun Suh, MD
role: Principal Investigator
affiliation: Seoul National University Department of Dermatology
last name: Hyuck Hoon Kwon, MD
role: Study Director
affiliation: Seoul National University Department of Dermatology
last name: Sun Yong Park
role: Study Director
affiliation: Seoul National University Department of Dermatology
last name: Seounguk Min
role: Study Director
affiliation: Seoul National University Department of Dermatology
last name: Jae Yoon Jung
role: Study Director
affiliation: Seoul National University Department of Dermatology
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Dae Hun Suh
investigator title: Professor
mesh term: Acne Vulgaris
mesh term: Lupeol