<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/NCT03281486</url>
  </required_header>
  <id_info>
    <org_study_id>LUD-105-17</org_study_id>
    <nct_id>NCT03281486</nct_id>
  </id_info>
  <brief_title>&quot;Hyaluronan&quot; Formulation for Type 2 Diabetic Patients With Dry Mouth</brief_title>
  <official_title>Clinical Evaluation of the Efficacy of &quot;Hyaluronan&quot; Formulation for Dry Mouth in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>You First Services</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>You First Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An increased incidence of dental caries in association with poorly controlled diabetes has&#xD;
      also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of&#xD;
      patients with diabetes, Without adequate saliva production, both hard and soft tissues of the&#xD;
      mouth can be severely damaged and become more susceptible to infections. This 9 week,&#xD;
      cross-over group, randomized, single center, study will evaluate the efficacy of HA&#xD;
      formulation in alleviating dry mouth in type 2 diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relief from drymouth using VAS scoring</measure>
    <time_frame>9 weeks</time_frame>
    <description>Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dry Mouth</condition>
  <condition>Xerostomia</condition>
  <condition>Type 2 Diabetics</condition>
  <arm_group>
    <arm_group_label>HA formulation Oral Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HA formulation Oral Spray</intervention_name>
    <description>It is an HA formulation of FDA listed ingredients</description>
    <arm_group_label>HA formulation Oral Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo formulation without the active ingredients</description>
    <arm_group_label>Placebo Oral Spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient should be above 18 years of age.&#xD;
&#xD;
          2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or&#xD;
             have worsening of pre-existing dry mouth condition.&#xD;
&#xD;
          3. Ability to attend visits at the research site&#xD;
&#xD;
          4. Patient should be able to read and/or understand and sign the consent form and be&#xD;
             willing to participate in the research study&#xD;
&#xD;
          5. Agree to abstain from the use of any products for xerostomia other than those provided&#xD;
             in the study.&#xD;
&#xD;
          6. Agree to comply with the conditions and schedule of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with open mouth sores at study entry.&#xD;
&#xD;
          2. Any pathology that, based on the judgement of the researcher, could negatively affect&#xD;
             the oral mucosa and subsequent treatment for xerostomia.&#xD;
&#xD;
          3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the&#xD;
             study period&#xD;
&#xD;
          4. Subjects currently on medication or treatment for dry mouth/xerostomia&#xD;
&#xD;
          5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.&#xD;
&#xD;
          6. Subjects with soft or hard tissue tumor of the oral cavity.&#xD;
&#xD;
          7. Presence of severe gingivitis.&#xD;
&#xD;
          8. Chronic disease with concomitant oral manifestations other than xerostomia&#xD;
&#xD;
          9. History of radiation therapy to head and neck&#xD;
&#xD;
         10. Subjects with conditions the investigator may feel will interfere with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Endocrinology and Metabolism, Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</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>Xerostomia</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/NCT03281486
org study id: LUD-105-17
nct id: NCT03281486
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
An increased incidence of dental caries in association with poorly controlled diabetes has
      also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of
      patients with diabetes, Without adequate saliva production, both hard and soft tissues of the
      mouth can be severely damaged and become more susceptible to infections. This 9 week,
      cross-over group, randomized, single center, study will evaluate the efficacy of HA
      formulation in alleviating dry mouth in type 2 diabetic patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Relief from drymouth using VAS scoring
time frame: 9 weeks
description: Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring
arm group label: HA formulation Oral Spray
arm group type: Experimental
description: Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
arm group label: Placebo Oral Spray
arm group type: Placebo Comparator
description: Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
intervention type: Device
intervention name: HA formulation Oral Spray
description: It is an HA formulation of FDA listed ingredients
arm group label: HA formulation Oral Spray
intervention type: Device
intervention name: Placebo
description: Placebo formulation without the active ingredients
arm group label: Placebo Oral Spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Xerostomia