<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/NCT02214706</url>
  </required_header>
  <id_info>
    <org_study_id>EMC14022_POLAR</org_study_id>
    <nct_id>NCT02214706</nct_id>
  </id_info>
  <brief_title>Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus</brief_title>
  <official_title>Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve the therapeutic outcome of laser therapy for port&#xD;
      wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser&#xD;
      and topical sirolimus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first treatment period all patients will receive a total of five treatments with two&#xD;
      week intervals. Every patient will receive the following four treatments (utilizing a&#xD;
      template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus&#xD;
      application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment&#xD;
      followed by topical sirolimus application without Er:Yag laser ablation of the stratum&#xD;
      corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months&#xD;
      follow-up period, during the second treatment period, patients will receive an additional&#xD;
      five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the&#xD;
      most successful of the four treatment modalities as evaluated after the first treatment&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of efficacy / adverse events&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage clearance assessed colorimetrically</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Port-Wine Stain</condition>
  <arm_group>
    <arm_group_label>sirolimus topical 40microgram/cm2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sirolimus topical 40microgram/cm2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulsed Dye Laser + Erbium yag + sirolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulsed Dye Laser + Erbium yag laser + topical sirolimus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulsed Dye Laser + topical sirolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulsed Dye Laser + topical sirolimus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulsed Dye Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulsed Dye Laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sirolimus</intervention_name>
    <description>sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.</description>
    <arm_group_label>Pulsed Dye Laser + Erbium yag + sirolimus</arm_group_label>
    <arm_group_label>Pulsed Dye Laser + topical sirolimus</arm_group_label>
    <arm_group_label>sirolimus topical 40microgram/cm2</arm_group_label>
    <other_name>Rapamune</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erbium yag laser</intervention_name>
    <description>Er:Yag laser ablation of the stratum corneum</description>
    <arm_group_label>Pulsed Dye Laser + Erbium yag + sirolimus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed Dye Laser</intervention_name>
    <arm_group_label>Pulsed Dye Laser</arm_group_label>
    <arm_group_label>Pulsed Dye Laser + Erbium yag + sirolimus</arm_group_label>
    <arm_group_label>Pulsed Dye Laser + topical sirolimus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent;&#xD;
&#xD;
          -  Subject is ≥ 18 years of age at time of screening;&#xD;
&#xD;
          -  Subject has an extra-facial homogenous Port Wine Stain (PWS);&#xD;
&#xD;
          -  The PWS is large enough in size to fit one of the templates&#xD;
&#xD;
          -  Subject has not received any laser treatment of the PWS in the last 3 months (in the&#xD;
             treatment area);&#xD;
&#xD;
          -  The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion&#xD;
             of the investigator;&#xD;
&#xD;
          -  Screening blood safety values are within normal parameters or regarded as not&#xD;
             clinically significant in the opinion of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PWS with a nodular/hypertrophic component in the treatment area;&#xD;
&#xD;
          -  PWS on cosmetically unacceptable locations in the opinion of the investigator;&#xD;
&#xD;
          -  For women: pregnant or breast feeding during the treatment period;&#xD;
&#xD;
          -  Women of child-bearing potential, unless they are using adequate contraceptive&#xD;
             measures&#xD;
&#xD;
          -  Subject is known to have immune deficiency, or is immune compromised&#xD;
&#xD;
          -  Known allergy to sirolimus or other constituents of the study medication;&#xD;
&#xD;
          -  Incapacitated subjects;&#xD;
&#xD;
          -  Any medical or psychiatric condition which, in the investigator's opinion, would&#xD;
             preclude the participant from adhering to the protocol or completing the study per&#xD;
             protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martijn van Doorn, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>M.B.A. van Doorn</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma, Capillary</mesh_term>
    <mesh_term>Port-Wine Stain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</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/NCT02214706
org study id: EMC14022_POLAR
nct id: NCT02214706
lead sponsor: 
has dmc: No
The purpose of this study is to improve the therapeutic outcome of laser therapy for port
      wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser
      and topical sirolimus.
In the first treatment period all patients will receive a total of five treatments with two
      week intervals. Every patient will receive the following four treatments (utilizing a
      template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus
      application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment
      followed by topical sirolimus application without Er:Yag laser ablation of the stratum
      corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months
      follow-up period, during the second treatment period, patients will receive an additional
      five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the
      most successful of the four treatment modalities as evaluated after the first treatment
      period.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage clearance assessed colorimetrically
time frame: 10 weeks
arm group label: sirolimus topical 40microgram/cm2
arm group type: Experimental
description: sirolimus topical 40microgram/cm2
arm group label: Pulsed Dye Laser + Erbium yag + sirolimus
arm group type: Experimental
description: Pulsed Dye Laser + Erbium yag laser + topical sirolimus
arm group label: Pulsed Dye Laser + topical sirolimus
arm group type: Experimental
description: Pulsed Dye Laser + topical sirolimus
arm group label: Pulsed Dye Laser
arm group type: Experimental
description: Pulsed Dye Laser
intervention type: Drug
intervention name: Sirolimus
description: sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.
arm group label: Pulsed Dye Laser + Erbium yag + sirolimus
arm group label: Pulsed Dye Laser + topical sirolimus
arm group label: sirolimus topical 40microgram/cm2
other name: Rapamune
intervention type: Other
intervention name: Erbium yag laser
description: Er:Yag laser ablation of the stratum corneum
arm group label: Pulsed Dye Laser + Erbium yag + sirolimus
intervention type: Device
intervention name: Pulsed Dye Laser
arm group label: Pulsed Dye Laser
arm group label: Pulsed Dye Laser + Erbium yag + sirolimus
arm group label: Pulsed Dye Laser + topical sirolimus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martijn van Doorn, MD, Phd
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: M.B.A. van Doorn
investigator title: MD, PhD
mesh term: Hemangioma, Capillary
mesh term: Port-Wine Stain
mesh term: Sirolimus