<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/NCT02207881</url>
  </required_header>
  <id_info>
    <org_study_id>YSP-RMN3001-01</org_study_id>
    <nct_id>NCT02207881</nct_id>
  </id_info>
  <brief_title>A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung Shin Pharm. Ind. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yung Shin Pharm. Ind. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent herpes labialis are usually a minor malady of limited duration, although they are&#xD;
      often painful and are uniformly discomforting for patients. Oral antivirals represent an&#xD;
      advance in the treatment of recurrent herpes labialis, but the clinical implications are&#xD;
      modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the&#xD;
      duration of lesion episodes and pain by approximately one day. In recurrent HSV infections&#xD;
      including herpes labialis, many instances of viral re-activation occur without symptoms, and&#xD;
      can only be identified by detection of virus on the lips of infected individuals. In these&#xD;
      cases, the virus is cleared from the local site without the development of a classical&#xD;
      ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly&#xD;
      stops viral replication in the skin and also causes the development of the herpes lesion&#xD;
      prodrome and a considerable part of the symptoms associated with a classical ulcerative&#xD;
      herpes lesion. One could therefore predict that treatment with an antiviral drug alone would&#xD;
      help the immune system in shortening the virus replication, but may not substantially reduce&#xD;
      the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of&#xD;
      using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related&#xD;
      symptoms associated with the infection has been well established. We have found that a&#xD;
      topical formulation of VDO is useful for alleviating pain and inflammation associated with&#xD;
      infection caused by herpes virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the treatment of oral herpes labialis, it is desirable to have local absorption of the&#xD;
      drug to provide pain relief directly at the lesion sites while minimizing overall exposure.&#xD;
&#xD;
      The present study is designed to elucidate the effects of VDO ( on recurrent herpes simplex&#xD;
      labialis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event</measure>
    <time_frame>at the end of treatment (up to 10 days)</time_frame>
    <description>Incidences of adverse event</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the duration and severity of pain</measure>
    <time_frame>At the end of treatment (up to 10 days)</time_frame>
    <description>Pain intensity will be measured at baseline and in the Subject's DRC on a daily basis while receiving study drug until end of study. Pain and itching assessments will be using a Visual Analogue Scale (VAS) ranging 0 (no pain/itching) to 10 (the worst pain/itching imaginable).&#xD;
The subject will be asked the following question exactly as follows：「On a scale 1 to 10 where 0 means on pain/itching, and 10 means the worst possible pain/itching, rate the worst pain/itching that you have since last assessment」</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Herpes Labialis</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo gel, 25mg, 3 times up to 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VDO gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VDO gel 25mg, 3 times a day up to 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VDO gel</intervention_name>
    <description>VDO gel</description>
    <arm_group_label>VDO gel</arm_group_label>
    <other_name>RMN3001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>matching placebo gel</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>RMN3001 placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female in the age group 20 to 75 years old.&#xD;
&#xD;
          -  History of recurrent herpes labialis with at least one recurrence occurred during the&#xD;
             past twenty-four months.&#xD;
&#xD;
          -  Onset of prodrome, erythema or vesicle within 72 hours of initiation of treatment with&#xD;
             the study drug.&#xD;
&#xD;
          -  Subjects with previous herpes simplex labialis episodes must be healed for at least 14&#xD;
             days before the baseline.&#xD;
&#xD;
          -  Must be willing and able to participate and to provide written informed consent.&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative pregnancy test at&#xD;
             screening and agree to use a proper contraceptive method during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women during pregnancy, lactation or breastfeeding.&#xD;
&#xD;
          -  Subjects using topical steroids on or near the face or systemic (oral, intravenous)&#xD;
             steroids within 7 days prior to study drug administration; use of inhaled or nasal&#xD;
             spray steroids does not exclude a subject from the study.&#xD;
&#xD;
          -  Subjects have used anti-viral agents or NSAID in the preceding 7 days.&#xD;
&#xD;
          -  Subjects are unwilling to stop for using topical medical, OTC, cosmetic or facial skin&#xD;
             care products in or around the oral area during the study period.&#xD;
&#xD;
          -  Subjects with immunodeficiency disorders such as human immunodeficiency virus (HIV)&#xD;
             infection or receiving cancer chemotherapy.&#xD;
&#xD;
          -  Subjects who have a history of hypersensitivity to diclofenac, lidocaine or propylene&#xD;
             glycol.&#xD;
&#xD;
          -  Subjects who have a known hypersensitivity to local anesthetics of the amide type,&#xD;
             diclofenac, aspirin, or other NSAIDs.&#xD;
&#xD;
          -  Subjects who are taking antiarrhythmics drug during screening visit；&#xD;
&#xD;
          -  Subjects who have a history of asthma, urticaria, or other allergic-type reactions&#xD;
             after taking aspirin or other NSAIDs.&#xD;
&#xD;
          -  Subjects who use during the perioperative period in the setting of coronary artery&#xD;
             bypass graft (CABG) surgery within 6 months before the study drug using.&#xD;
&#xD;
          -  Subjects have history of substance abuse or psychiatric illness that would preclude&#xD;
             compliance with the protocol.&#xD;
&#xD;
          -  Subjects who have serious, unstable, or clinically significant medical or&#xD;
             psychological conditions, which, in the opinion of the investigator(s), would&#xD;
             compromise the subject's participation in the study (including clinically significant&#xD;
             dehydration or unstable vital signs).&#xD;
&#xD;
          -  Subjects taking or having taken any other experimental drugs, drugs not approved in&#xD;
             Taiwan, or participating in or having participated in other clinical studies in the 30&#xD;
             days prior to this clinical trial.&#xD;
&#xD;
          -  Subjects who are considered unreliable as to medication compliance or adherence to&#xD;
             scheduled appointments, or inappropriate for inclusion determined by the&#xD;
             investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HUNG-MING WU, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>herpes labialis</keyword>
  <keyword>cold sore</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Labialis</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/NCT02207881
org study id: YSP-RMN3001-01
nct id: NCT02207881
lead sponsor: 
collaborator: 
has dmc: No
Recurrent herpes labialis are usually a minor malady of limited duration, although they are
      often painful and are uniformly discomforting for patients. Oral antivirals represent an
      advance in the treatment of recurrent herpes labialis, but the clinical implications are
      modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the
      duration of lesion episodes and pain by approximately one day. In recurrent HSV infections
      including herpes labialis, many instances of viral re-activation occur without symptoms, and
      can only be identified by detection of virus on the lips of infected individuals. In these
      cases, the virus is cleared from the local site without the development of a classical
      ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly
      stops viral replication in the skin and also causes the development of the herpes lesion
      prodrome and a considerable part of the symptoms associated with a classical ulcerative
      herpes lesion. One could therefore predict that treatment with an antiviral drug alone would
      help the immune system in shortening the virus replication, but may not substantially reduce
      the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of
      using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related
      symptoms associated with the infection has been well established. We have found that a
      topical formulation of VDO is useful for alleviating pain and inflammation associated with
      infection caused by herpes virus.
In the treatment of oral herpes labialis, it is desirable to have local absorption of the
      drug to provide pain relief directly at the lesion sites while minimizing overall exposure.

      The present study is designed to elucidate the effects of VDO ( on recurrent herpes simplex
      labialis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Adverse event
time frame: at the end of treatment (up to 10 days)
description: Incidences of adverse event
measure: the duration and severity of pain
time frame: At the end of treatment (up to 10 days)
description: Pain intensity will be measured at baseline and in the Subject's DRC on a daily basis while receiving study drug until end of study. Pain and itching assessments will be using a Visual Analogue Scale (VAS) ranging 0 (no pain/itching) to 10 (the worst pain/itching imaginable).
The subject will be asked the following question exactly as follows：「On a scale 1 to 10 where 0 means on pain/itching, and 10 means the worst possible pain/itching, rate the worst pain/itching that you have since last assessment」
arm group label: placebo
arm group type: Placebo Comparator
description: placebo gel, 25mg, 3 times up to 10 days
arm group label: VDO gel
arm group type: Experimental
description: VDO gel 25mg, 3 times a day up to 10 days
intervention type: Drug
intervention name: VDO gel
description: VDO gel
arm group label: VDO gel
other name: RMN3001
intervention type: Drug
intervention name: placebo
description: matching placebo gel
arm group label: placebo
other name: RMN3001 placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: HUNG-MING WU, MD, PhD
role: Principal Investigator
affiliation: Changhua Christian Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Herpes Simplex
mesh term: Herpes Labialis