xml: <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/NCT05995626</url>
    </required_header>
    <id_info>
      <org_study_id>0210-23-FB</org_study_id>
      <nct_id>NCT05995626</nct_id>
    </id_info>
    <brief_title>Hyaluronidase Via LADD Scleroderma-induced Microstomia</brief_title>
    <official_title>Hyaluronidase Via Laser-Assisted Drug Delivery for the Treatment of Scleroderma-induced Microstomia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nebraska</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Nebraska</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Two treatment methods, ablative CO2 laser and intradermal hyaluronidase, will be combined to&#xD;
        maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown&#xD;
        to be effective for the administration of medications in diverse skin diseases but not&#xD;
        previously reported for the treatment of scleroderma-induced microstomia. By using this laser&#xD;
        technique, the investigator can reduce the pain of typical hyaluronidase injections and reap&#xD;
        the therapeutic benefit of the laser treatment itself. The investigator's goal is to create&#xD;
        greater mouth mobility for chewing and speaking as well as improved oral hygiene,&#xD;
        self-esteem, and overall quality of life. Each participant will undergo three separate laser&#xD;
        sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three&#xD;
        months after the last laser session to evaluate the response.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigator will combine two treatment modalities, ablative CO2 laser,&#xD;
        and intradermal hyaluronidase, via laser-assisted drug delivery. The investigator's goal is&#xD;
        to maximize the therapeutic potential of each of these therapeutic interventions by combining&#xD;
        them. Laser-assisted drug delivery (LADD) has been shown to be an effective modality for the&#xD;
        administration of medications in diverse cutaneous diseases but has not been previously&#xD;
        reported for the treatment of scleroderma-induced microstomia. By using an ablative&#xD;
        fractional CO2 laser, the investigator can facilitate both the intradermal administration of&#xD;
        hyaluronidase and reap the therapeutic benefit of the laser treatment itself. LADD of&#xD;
        hyaluronidase has the additional advantage of being less painful and likely better tolerated&#xD;
        than intradermal hyaluronidase injections, which typically require painful infraorbital and&#xD;
        mental nerve blocks. The investigator's goal is to provide patients with a novel, effective,&#xD;
        and less painful option for the treatment of scleroderma-induced microstomia, leading to&#xD;
        greater mouth mobility for mastication and phonation as well as improved oral hygiene,&#xD;
        self-esteem, and overall quality of life. Ten patients with scleroderma-induced microstomia&#xD;
        will be selected primarily from the scleroderma patient population at UNMC Dermatology as&#xD;
        well as from a local non-profit scleroderma support group. Each patient will undergo three&#xD;
        separate laser sessions. On each occasion, we will treat the perioral area with 200 units of&#xD;
        hyaluronidase, administered via LADD using an ablative fractional CO2 laser. These&#xD;
        appointments will be scheduled at 4 to 8-week intervals, depending on the patient's tolerance&#xD;
        to laser therapy and availability. Patients will also complete a nonprocedural follow-up&#xD;
        visit three months after the last laser session to evaluate for a sustained response.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 18, 2023</start_date>
    <completion_date type="Anticipated">October 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 18, 2024</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>Difference in interincisal distance</measure>
      <time_frame>6 months</time_frame>
      <description>Our aim is to increase interincisal distance. We will be collecting these measurements before and after every treatment and on follow-up visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in Mouth Handicap In Systemic Sclerosis score</measure>
      <time_frame>6 months</time_frame>
      <description>Mouth handicap in systemic sclerosis score is a subjective measurement of the impact of microstomia in scleroderma patients. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem. We aim to evaluate the score difference before and after the completion of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in inter-labial and inter-commissural distance</measure>
      <time_frame>6 months</time_frame>
      <description>Our aim is to increase both these distances. We will be collecting these measurements before and after every treatment and on follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life RAND 36-item Health Survey 1.0</measure>
      <time_frame>6 months</time_frame>
      <description>We aim to assess the impact of our treatment modality on quality of life. Patients will fill out a questionnaire before the start and after the completion of treatment to evaluate this.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Satisfaction</measure>
      <time_frame>6 months</time_frame>
      <description>We will evaluate patients' satisfaction with treatment with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Microstomia</condition>
    <condition>Scleroderma</condition>
    <arm_group>
      <arm_group_label>Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Uncover a safe, efficacious, and tolerable alternate treatment modality for patients with scleroderma-induced microstomia. Evaluate disease severity and patient quality of life before and after alternative treatment is administered</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hyaluronidase</intervention_name>
      <description>hyaluronidase injection is used during fluid administration under the skin to help achieve hydration, to increase the dispersion and absorption of other injected drugs, or during some types of urography (imaging of the urinary tract) to help improve resorption of drugs used during the procedure.</description>
      <arm_group_label>Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery</arm_group_label>
      <other_name>Vitrase</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>co2 laser</intervention_name>
      <description>CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue. The focus tissue will then be cleanly incised. They have greater precision for laser surgery and have more flexibility in tip sizes and protocols.</description>
      <arm_group_label>Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient being seen at the Lauritzen Outpatient Clinic or Westroads Clinic, Department&#xD;
               of Dermatology&#xD;
  &#xD;
            -  Patient diagnosed with scleroderma-induced microstomia&#xD;
  &#xD;
            -  Capable and willing to participate&#xD;
  &#xD;
            -  No history of medical conditions that will interfere with successful completion of the&#xD;
               study such as severe dementia or seizure disorder&#xD;
  &#xD;
            -  Patients aged 19 or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant and breastfeeding women&#xD;
  &#xD;
            -  Patients 18 years or younger&#xD;
  &#xD;
            -  In patients with bee stings or bites hyaluronidase is to be used cautiously&#xD;
  &#xD;
            -  Patients with infection or inflammation in or near the area of treatment&#xD;
  &#xD;
            -  Patients with prior treatment with hyaluronidase, LADD or ablative CO2 laser&#xD;
               treatment, or have a history of adverse reactions to the treatments&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah L Lonowski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah L Lonowski, MD</last_name>
      <phone>402-559-9784</phone>
      <email>slonowski@unmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Nebraska Medical Center, Lauritzen Outpatient Center</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68105</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Megan Wackel, MS</last_name>
        <phone>402-559-3825</phone>
        <email>megan.wackel@unmc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nebraska Medicine, Dermatology Westroads</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sarah Lonowski, MD</last_name>
        <phone>402-559-9784</phone>
        <email>slonowski@unmc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Microstomia</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
      <mesh_term>Scleroderma, Localized</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995626
  org study id: 0210-23-FB
  nct id: NCT05995626
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: Yes
  Two treatment methods, ablative CO2 laser and intradermal hyaluronidase, will be combined to
        maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown
        to be effective for the administration of medications in diverse skin diseases but not
        previously reported for the treatment of scleroderma-induced microstomia. By using this laser
        technique, the investigator can reduce the pain of typical hyaluronidase injections and reap
        the therapeutic benefit of the laser treatment itself. The investigator's goal is to create
        greater mouth mobility for chewing and speaking as well as improved oral hygiene,
        self-esteem, and overall quality of life. Each participant will undergo three separate laser
        sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three
        months after the last laser session to evaluate the response.
  In this study, the investigator will combine two treatment modalities, ablative CO2 laser,
        and intradermal hyaluronidase, via laser-assisted drug delivery. The investigator's goal is
        to maximize the therapeutic potential of each of these therapeutic interventions by combining
        them. Laser-assisted drug delivery (LADD) has been shown to be an effective modality for the
        administration of medications in diverse cutaneous diseases but has not been previously
        reported for the treatment of scleroderma-induced microstomia. By using an ablative
        fractional CO2 laser, the investigator can facilitate both the intradermal administration of
        hyaluronidase and reap the therapeutic benefit of the laser treatment itself. LADD of
        hyaluronidase has the additional advantage of being less painful and likely better tolerated
        than intradermal hyaluronidase injections, which typically require painful infraorbital and
        mental nerve blocks. The investigator's goal is to provide patients with a novel, effective,
        and less painful option for the treatment of scleroderma-induced microstomia, leading to
        greater mouth mobility for mastication and phonation as well as improved oral hygiene,
        self-esteem, and overall quality of life. Ten patients with scleroderma-induced microstomia
        will be selected primarily from the scleroderma patient population at UNMC Dermatology as
        well as from a local non-profit scleroderma support group. Each patient will undergo three
        separate laser sessions. On each occasion, we will treat the perioral area with 200 units of
        hyaluronidase, administered via LADD using an ablative fractional CO2 laser. These
        appointments will be scheduled at 4 to 8-week intervals, depending on the patient's tolerance
        to laser therapy and availability. Patients will also complete a nonprocedural follow-up
        visit three months after the last laser session to evaluate for a sustained response.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Difference in interincisal distance
  time frame: 6 months
  description: Our aim is to increase interincisal distance. We will be collecting these measurements before and after every treatment and on follow-up visit.
  measure: Difference in Mouth Handicap In Systemic Sclerosis score
  time frame: 6 months
  description: Mouth handicap in systemic sclerosis score is a subjective measurement of the impact of microstomia in scleroderma patients. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem. We aim to evaluate the score difference before and after the completion of treatment.
  measure: Differences in inter-labial and inter-commissural distance
  time frame: 6 months
  description: Our aim is to increase both these distances. We will be collecting these measurements before and after every treatment and on follow-up visit.
  measure: Quality of life RAND 36-item Health Survey 1.0
  time frame: 6 months
  description: We aim to assess the impact of our treatment modality on quality of life. Patients will fill out a questionnaire before the start and after the completion of treatment to evaluate this.
  measure: Treatment Satisfaction
  time frame: 6 months
  description: We will evaluate patients' satisfaction with treatment with a Likert Scale, 1 = very dissatisfied and 5 = very satisfied.
  arm group label: Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery
  arm group type: Experimental
  description: Uncover a safe, efficacious, and tolerable alternate treatment modality for patients with scleroderma-induced microstomia. Evaluate disease severity and patient quality of life before and after alternative treatment is administered
  intervention type: Drug
  intervention name: Hyaluronidase
  description: hyaluronidase injection is used during fluid administration under the skin to help achieve hydration, to increase the dispersion and absorption of other injected drugs, or during some types of urography (imaging of the urinary tract) to help improve resorption of drugs used during the procedure.
  arm group label: Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery
  other name: Vitrase
  intervention type: Device
  intervention name: co2 laser
  description: CO2 lasers use an aiming beam to see where the treatment beam will impact the focus tissue. The focus tissue will then be cleanly incised. They have greater precision for laser surgery and have more flexibility in tip sizes and protocols.
  arm group label: Ablative CO2 laser, and intradermal hyaluronidase, via laser-assisted drug delivery
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah L Lonowski, MD
  role: Principal Investigator
  affiliation: University of Nebraska
  last name: Sarah L Lonowski, MD
  phone: 402-559-9784
  email: slonowski@unmc.edu
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Microstomia
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Scleroderma, Localized