<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/NCT01676792</url>
  </required_header>
  <id_info>
    <org_study_id>100CT221</org_study_id>
    <secondary_id>100CT221</secondary_id>
    <nct_id>NCT01676792</nct_id>
  </id_info>
  <brief_title>SR-T100 Gel Efficacy &amp; Safety Study for Vulva Pre-cancerous Lesions &amp; Cutaneous Condyloma</brief_title>
  <official_title>A Pilot Study to Assess the Efficacy &amp; Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) &amp; Cutaneous Condyloma(External Genital Warts; EGWs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>G&amp;E Herbal Biotechnology Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical study is to evaluate the efficacy &amp; safety of SR-T100 gel (2.3% of SM in&#xD;
      Solanum undatum plant extract) in patients with VIN(s) or EGW(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, pilot study to evaluate the efficacy &amp; safety profiles of SR-T100 gel in&#xD;
      treating patients with VINs or EGWs. Male &amp; female older than 20 years old have at least one&#xD;
      VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The&#xD;
      primary endpoint is evaluated based on patients who has received 16-week treatment and&#xD;
      presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be&#xD;
      evaluated based on all patients with measurable values for VINs or EGWs, recruited patients&#xD;
      in this study has never had experiencs associated with prior SR-T100 treatment of any sorts&#xD;
      during their life time before becoming a participant in this study. The study plans to&#xD;
      recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total&#xD;
      of 40 patients involved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients achieve greater than or equal to 75% lesion size reduction</measure>
    <time_frame>20 weeks (16 weeks treatment period + 4 weeks follow-up period)</time_frame>
    <description>Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total clearance rate</measure>
    <time_frame>20 weeks (16 weeks treatment period + 4 weeks follow-up period)</time_frame>
    <description>Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial clearance rate</measure>
    <time_frame>20 weeks (16weeks treatment period + 4 weeks follow-up period</time_frame>
    <description>Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety</measure>
    <time_frame>16 weeks</time_frame>
    <description>To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs &amp; laboratory data changes.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Vulvar Intraepithelial Neoplasia</condition>
  <condition>Genital Warts</condition>
  <arm_group>
    <arm_group_label>Lesion reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SR-T100 gel with 2.3% of SM in Solanum undatum plant extract</intervention_name>
    <description>Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon &amp; before bed time. Medication should be reapply after bathing or cleaning.</description>
    <arm_group_label>Lesion reduction</arm_group_label>
    <other_name>SR-T100 gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        (EGW group)Inclusion Criteria:&#xD;
&#xD;
          -  Male &amp; female patients older than 20 years old presents at least one pathologically&#xD;
             confirmed with histopathology EGW with lesion size greater than 5mm in diameter.&#xD;
&#xD;
        (EGW group)Exclusion Criteria:&#xD;
&#xD;
          -  Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell&#xD;
             carcinoma, having treated with other investigational drugs within 30 days, pregnancy &amp;&#xD;
             lactating females, female with pregnancy potential without using effective boundary&#xD;
             barrier or patients with immune-deficience.&#xD;
&#xD;
        (VIN group)Inclusion Criteria:&#xD;
&#xD;
          -  Female patients older than 20 years old presents at least one histopathologically&#xD;
             confirmed VIN with lesion size greater than 5mm in diameter.&#xD;
&#xD;
        (VIN group)Exclusion Criteria:&#xD;
&#xD;
          -  Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell&#xD;
             carcinoma, having treated with other investigational drugs within 30 days, pregnancy &amp;&#xD;
             lactating females, female with pregnancy potential without using effective boundary&#xD;
             barrier or patients with immune-deficience.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keng-Fu Hsu, MD, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng-Kung University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>744</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>April 21, 2014</last_update_submitted>
  <last_update_submitted_qc>April 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>condyloma acuminate</keyword>
  <keyword>ano-genital warts</keyword>
  <keyword>genital warts</keyword>
  <keyword>cutaneous condyloma</keyword>
  <keyword>Vulva pre-cancerous lesions</keyword>
  <keyword>Vulvar Intraepitheral Neoplasia</keyword>
  <keyword>VIN</keyword>
  <keyword>EGW</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warts</mesh_term>
    <mesh_term>Condylomata Acuminata</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_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/NCT01676792
org study id: 100CT221
secondary id: 100CT221
nct id: NCT01676792
lead sponsor: 
collaborator: 
has dmc: No
This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in
      Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
An open-label, pilot study to evaluate the efficacy & safety profiles of SR-T100 gel in
      treating patients with VINs or EGWs. Male & female older than 20 years old have at least one
      VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The
      primary endpoint is evaluated based on patients who has received 16-week treatment and
      presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be
      evaluated based on all patients with measurable values for VINs or EGWs, recruited patients
      in this study has never had experiencs associated with prior SR-T100 treatment of any sorts
      during their life time before becoming a participant in this study. The study plans to
      recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total
      of 40 patients involved.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients achieve greater than or equal to 75% lesion size reduction
time frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
description: Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment
measure: Total clearance rate
time frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
description: Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.
measure: Partial clearance rate
time frame: 20 weeks (16weeks treatment period + 4 weeks follow-up period
description: Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.
measure: Safety
time frame: 16 weeks
description: To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes.
arm group label: Lesion reduction
arm group type: Experimental
intervention type: Drug
intervention name: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
description: Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon & before bed time. Medication should be reapply after bathing or cleaning.
arm group label: Lesion reduction
other name: SR-T100 gel
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Keng-Fu Hsu, MD, PhD.
role: Principal Investigator
affiliation: National Cheng-Kung University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Warts
mesh term: Condylomata Acuminata
mesh term: Neoplasms
mesh term: Carcinoma in Situ