<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/NCT03238469</url>
  </required_header>
  <id_info>
    <org_study_id>WAVE trial</org_study_id>
    <nct_id>NCT03238469</nct_id>
  </id_info>
  <brief_title>Microwave Ablation in Mild Axillary Hidradenitis Suppurativa</brief_title>
  <acronym>WAVE</acronym>
  <official_title>Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.B.A. van Doorn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With microwave ablation (MWA), using the heat generated from electromagnetic waves in the&#xD;
      microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated&#xD;
      through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis&#xD;
      (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat&#xD;
      glands, the investigators hypothesize a beneficial and long-term sustainable preventive&#xD;
      effect of MWA in HS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease of the hair follicle,&#xD;
      and is predominantly located in the axillary, inguinal and anogenital regions. Current&#xD;
      treatment options for HS include systemic oral antibiotics, anti-TNFα, and surgery, which are&#xD;
      used to treat the consequences rather than treating the primary pathogenesis of HS. With&#xD;
      microwave ablation (MWA), using the heat generated from electromagnetic waves in the&#xD;
      microwave energy spectrum, hair follicles, eccrine and apocrine glands in the (hypo)dermis&#xD;
      are ablated through thermolysis. MWA was recently approved for the treatment of axillary&#xD;
      hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of&#xD;
      hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable&#xD;
      preventive effect of MWA in HS patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Negative clinical outcomes&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</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>
    <intervention_model_description>Randomized intra-patient controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hidradenitis Suppurativa Clinical Response (HiSCR50)</measure>
    <time_frame>6 months</time_frame>
    <description>The proposed definition of 50% responders to treatment (HiSCR50 achievers) is: (i) at least a 50% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hidradenitis Suppurativa Clinical Response (HiSCR30)</measure>
    <time_frame>6 months</time_frame>
    <description>The proposed definition of 30% responders to treatment (HiSCR30 achievers) is: (i) at least a 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported number of HS flares</measure>
    <time_frame>6 months</time_frame>
    <description>The number of HS flares in the treated and untreated axillae. At baseline retrospective assessment on last month, and during follow-up prospective assessment using a diary where patients will report the number of acute boils per axilla.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of hair containing follicles</measure>
    <time_frame>6 months</time_frame>
    <description>Dermatoscopy of three fields per axilla</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of sweat production</measure>
    <time_frame>6 months</time_frame>
    <description>Starch-Iodine test per axillary region</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported pain and pruritus</measure>
    <time_frame>6 months</time_frame>
    <description>Numerical rating scale (NRS) to assess pain and itch per axillary region</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of (treatment-emergent) adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Safety and tolerability of the treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <condition>Acne Inversa</condition>
  <arm_group>
    <arm_group_label>Microwave ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No microwave ablation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microwave ablation</intervention_name>
    <description>A one-sided (either right or left axillary area) single MWA treatment using a miraDry system. The miraDry device has a microwave output frequency of 5.8 GHz and microwave energy level settings ranging from 1 to 5, corresponding with a delivery time in seconds between 2.40 sec and 3.00 sec. For this study standard 5 (i.e. 3.00 sec) is set as treatment setting.</description>
    <arm_group_label>Microwave ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥ 18 years of age) male or female patients with mild HS and able to&#xD;
             participate, willing to give written informed consent and to comply with the study&#xD;
             restrictions;&#xD;
&#xD;
          -  Minimum of 3 AN-count located in each axilla;&#xD;
&#xD;
          -  Maximum of 5 AN-count located in each axilla.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with &gt;1 abscesses or draining fistulas per axillary region;&#xD;
&#xD;
          -  AN-count ≥ 5 in other regions than the axillary area;&#xD;
&#xD;
          -  Any current and / or recurrent clinically significant skin condition in the treatment&#xD;
             area other than HS;&#xD;
&#xD;
          -  Surgical scars covering more than 25% of each individual axillary area;&#xD;
&#xD;
          -  Open surgical wound(s) in the axillary areas prior to randomization;&#xD;
&#xD;
          -  Use of anti-inflammatory or immunomodulatory medication (intralesional&#xD;
             corticosteroids, oral antibiotics, biologics, prednisone) within 2 weeks prior to&#xD;
             randomization;&#xD;
&#xD;
          -  Contraindication for miraDry therapy;&#xD;
&#xD;
          -  Heart pacemakers and other electronic device implants;&#xD;
&#xD;
          -  Supplemental oxygen;&#xD;
&#xD;
          -  Resistance to or history of intolerance of local anesthesia including lidocaine and&#xD;
             epinephrine;&#xD;
&#xD;
          -  Previous use of miraDry therapy or MWA in the axillary area;&#xD;
&#xD;
          -  Previous use of successful laser or light therapy for hair removal in the axillary&#xD;
             area;&#xD;
&#xD;
          -  Use of botulinum toxin injections 6 months prior to randomization;&#xD;
&#xD;
          -  Use of aluminiumhydroxychloride 1 month prior to randomization;&#xD;
&#xD;
          -  Pregnant or lactating women at randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Errol Prens, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasmus University Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>
  <keyword>Microwave Ablation</keyword>
  <keyword>Hair Follicle</keyword>
  <keyword>Sweat gland</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>metc@erasmusmc.nl</ipd_description>
  </patient_data>
  <!-- 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/NCT03238469
org study id: WAVE trial
nct id: NCT03238469
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
With microwave ablation (MWA), using the heat generated from electromagnetic waves in the
      microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated
      through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis
      (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat
      glands, the investigators hypothesize a beneficial and long-term sustainable preventive
      effect of MWA in HS patients.
Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease of the hair follicle,
      and is predominantly located in the axillary, inguinal and anogenital regions. Current
      treatment options for HS include systemic oral antibiotics, anti-TNFα, and surgery, which are
      used to treat the consequences rather than treating the primary pathogenesis of HS. With
      microwave ablation (MWA), using the heat generated from electromagnetic waves in the
      microwave energy spectrum, hair follicles, eccrine and apocrine glands in the (hypo)dermis
      are ablated through thermolysis. MWA was recently approved for the treatment of axillary
      hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of
      hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable
      preventive effect of MWA in HS patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized intra-patient controlled trial.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hidradenitis Suppurativa Clinical Response (HiSCR50)
time frame: 6 months
description: The proposed definition of 50% responders to treatment (HiSCR50 achievers) is: (i) at least a 50% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
measure: Hidradenitis Suppurativa Clinical Response (HiSCR30)
time frame: 6 months
description: The proposed definition of 30% responders to treatment (HiSCR30 achievers) is: (i) at least a 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
measure: Patient-reported number of HS flares
time frame: 6 months
description: The number of HS flares in the treated and untreated axillae. At baseline retrospective assessment on last month, and during follow-up prospective assessment using a diary where patients will report the number of acute boils per axilla.
measure: Average number of hair containing follicles
time frame: 6 months
description: Dermatoscopy of three fields per axilla
measure: Extent of sweat production
time frame: 6 months
description: Starch-Iodine test per axillary region
measure: Patient-reported pain and pruritus
time frame: 6 months
description: Numerical rating scale (NRS) to assess pain and itch per axillary region
measure: Incidence of (treatment-emergent) adverse events
time frame: 6 months
description: Safety and tolerability of the treatment
arm group label: Microwave ablation
arm group type: Experimental
description: One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.
arm group label: No microwave ablation
arm group type: No Intervention
description: Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.
intervention type: Device
intervention name: Microwave ablation
description: A one-sided (either right or left axillary area) single MWA treatment using a miraDry system. The miraDry device has a microwave output frequency of 5.8 GHz and microwave energy level settings ranging from 1 to 5, corresponding with a delivery time in seconds between 2.40 sec and 3.00 sec. For this study standard 5 (i.e. 3.00 sec) is set as treatment setting.
arm group label: Microwave ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Errol Prens, MD, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: M.B.A. van Doorn
investigator title: MD, PhD
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No
ipd description: metc@erasmusmc.nl