<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/NCT01685398</url>
  </required_header>
  <id_info>
    <org_study_id>088/2555(EC4)</org_study_id>
    <nct_id>NCT01685398</nct_id>
  </id_info>
  <brief_title>Topical Timolol for Superficial Infantile Hemangioma</brief_title>
  <official_title>Treatment of Cutaneous Hemangioma of Infancy With Topical 0.5% Timolol Maleate Eye Drop Compared With Placebo in Pediatric Patients, Siriraj Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.&#xD;
      The characteristic natural history of this tumor is rapid growth in the first year of life&#xD;
      and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early&#xD;
      intervention in superficial IH may help to minimize the risk of residual aesthetic problems.&#xD;
      Topical timolol, a non selective beta-blocker, is an emerging treatment which has been&#xD;
      reported in efficacy and safety for the treatment of IH. However, the reported studies were&#xD;
      case-series or small study. This study is a prospective double-blind,randomized-controlled&#xD;
      study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in&#xD;
      superficial IH. The patient will be treated with topical timolol for at least 6 months and&#xD;
      instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the&#xD;
      entire lesion with a finger. Photographs of the lesion will be taken at the baseline and&#xD;
      every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2&#xD;
      investigators independently to determine the change in lesion size and visual analogue scale&#xD;
      of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate&#xD;
      solution in treatment of infantile hemangioma compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 3</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo</measure>
    <time_frame>6 months</time_frame>
    <description>Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma</measure>
    <time_frame>6 months</time_frame>
    <description>The side effects of 0.5% timolol maleate solution include bradycardia, dizziness, irritant contact dermatitis, allergic contact dermatitis, fatigue, nausea, diarrhea,and insomnia. To determine the side effects, investigators will monitor the vital signs of the patients every follow-up visit and ask the caretakers about the side effects. Furthermore, every patients will receive the dairy to record the frequency of drug usage and side effects found.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Hemangioma</condition>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.5% timolol maleate eye drop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% timolol maleate solution 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% timolol maleate eye drop</intervention_name>
    <arm_group_label>0.5% timolol maleate eye drop</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>normal saline</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who is less than 2 years&#xD;
&#xD;
          -  Patient who has been diagnosed with superficial infantile hemangioma&#xD;
&#xD;
          -  The tumor which has been in proliferative or plateau phase&#xD;
&#xD;
          -  There is no indication for systemic treatment&#xD;
&#xD;
          -  Informed consent is obtained from the parent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who has the indication for systemic therapy&#xD;
&#xD;
          -  Patient who is treated by the other modality such as laser treatment&#xD;
&#xD;
          -  Patient who has underlying disease treated by beta blocker, corticosteroids,&#xD;
             interferon, cyclophosphamide or vincristine&#xD;
&#xD;
          -  Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac&#xD;
             condition prove to heart block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rattanavalai Nitiyarom, MD</last_name>
    <phone>6624195678</phone>
    <email>rattanavalai.nit@mahidol.ac.th</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital Mahidol University</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rattanavalai Nitiyarom, MD</last_name>
      <phone>6624195678</phone>
    </contact>
    <investigator>
      <last_name>Rattanavalai Nitiyarom, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</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>Hemangioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Timolol</mesh_term>
    <mesh_term>Ophthalmic Solutions</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/NCT01685398
org study id: 088/2555(EC4)
nct id: NCT01685398
lead sponsor: 
has dmc: No
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.
      The characteristic natural history of this tumor is rapid growth in the first year of life
      and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early
      intervention in superficial IH may help to minimize the risk of residual aesthetic problems.
      Topical timolol, a non selective beta-blocker, is an emerging treatment which has been
      reported in efficacy and safety for the treatment of IH. However, the reported studies were
      case-series or small study. This study is a prospective double-blind,randomized-controlled
      study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in
      superficial IH. The patient will be treated with topical timolol for at least 6 months and
      instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the
      entire lesion with a finger. Photographs of the lesion will be taken at the baseline and
      every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2
      investigators independently to determine the change in lesion size and visual analogue scale
      of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate
      solution in treatment of infantile hemangioma compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo
time frame: 6 months
description: Percent changes in visual analogue scale of the lesion color and global assessment scale of the lesion after treatment
measure: Side effects of the topical 0.5% timolol maleate solution in treatment of infantile hemangioma
time frame: 6 months
description: The side effects of 0.5% timolol maleate solution include bradycardia, dizziness, irritant contact dermatitis, allergic contact dermatitis, fatigue, nausea, diarrhea,and insomnia. To determine the side effects, investigators will monitor the vital signs of the patients every follow-up visit and ask the caretakers about the side effects. Furthermore, every patients will receive the dairy to record the frequency of drug usage and side effects found.
arm group label: normal saline
arm group type: Placebo Comparator
description: normal saline 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger
arm group label: 0.5% timolol maleate eye drop
arm group type: Experimental
description: 0.5% timolol maleate solution 1-2 drops put on the hemangioma lesion 4 times a day and rub over the entire lesion with a finger
intervention type: Drug
intervention name: 0.5% timolol maleate eye drop
arm group label: 0.5% timolol maleate eye drop
intervention type: Drug
intervention name: Normal saline
arm group label: normal saline
other name: Saline
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rattanavalai Nitiyarom, MD
phone: 6624195678
email: rattanavalai.nit@mahidol.ac.th
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
responsible party type: Sponsor
mesh term: Hemangioma
mesh term: Timolol
mesh term: Ophthalmic Solutions