<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/NCT01708213</url>
  </required_header>
  <id_info>
    <org_study_id>CP 10664</org_study_id>
    <nct_id>NCT01708213</nct_id>
  </id_info>
  <brief_title>Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device</brief_title>
  <official_title>A Multi-center, Open-label, Prospective Study of Implanted Cross-linked HA Device, Aline HA, for Soft Tissue Augmentation, to Treat Only One Anatomic Feature in up to 100 Subjects for 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TauTona Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TauTona Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as&#xD;
      determined by clinical assessment of treatment sites and routine tracking of adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA,&#xD;
      for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</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>Assessment of Treatment Site Responses Post Procedure</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds</measure>
    <time_frame>6 months</time_frame>
    <description>For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).&#xD;
WSS:&#xD;
(0) - No wrinkle&#xD;
- Just perceptible wrinkle&#xD;
- Shallow wrinkle&#xD;
- Moderately deep wrinkle&#xD;
- Deep wrinkle, well-defined edges&#xD;
- Very deep wrinkle, redundant fold</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS</measure>
    <time_frame>6 months</time_frame>
    <description>This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Disorder of Soft Tissue</condition>
  <arm_group>
    <arm_group_label>Dermal Filler - Aline HA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single armed study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aline HA</intervention_name>
    <description>Implantable dermal filler</description>
    <arm_group_label>Dermal Filler - Aline HA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must be ≥ 21 and ≤ 70 years of age.&#xD;
&#xD;
          2. The patient must be willing and able to provide informed consent.&#xD;
&#xD;
          3. The patient must be able to read.&#xD;
&#xD;
          4. The patient is willing and able to comply with the study protocol.&#xD;
&#xD;
          5. The patient is seeking soft tissue augmentation&#xD;
&#xD;
          6. The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for any NLF to be&#xD;
             treated.&#xD;
&#xD;
          7. The patient agrees to follow-up examinations out to 6 months post final treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion Criteria: 1) The patient has had (or plans to have) cosmetic procedures to&#xD;
             treat the intended treatment area, such as:&#xD;
&#xD;
               1. Ablative or non-ablative resurfacing procedures including but not limited to&#xD;
                  medium depth or deeper chemical peeling, dermabrasion, laser resurfacing or&#xD;
                  fractional resurfacing that would affect the treatment area within the last 12&#xD;
                  months.&#xD;
&#xD;
               2. Laser or light based therapy that would affect the treatment area within the last&#xD;
                  6 months.&#xD;
&#xD;
               3. Face, neck or brow lift or other surgical procedure of the head and neck that&#xD;
                  would affect the treatment area in the last 18 months.&#xD;
&#xD;
               4. Non-permanent dermal filler treatment in the treatment area within the last 9&#xD;
                  months.&#xD;
&#xD;
               5. Permanent implant or dermal filler treatment in the treatment area at any point&#xD;
                  in time.&#xD;
&#xD;
               6. Neurotoxin treatment that would affect the treatment area in the last 6 months,&#xD;
                  if the treatment area is below the eyes.&#xD;
&#xD;
               7. Neurotoxin treatment that would affect the treatment area in the last 9 months,&#xD;
                  if the treatment area is above the eyes.&#xD;
&#xD;
                  2) The patient has had or plans to use a pharmaceutical (topical or oral)&#xD;
                  anti-wrinkle product or other products (e.g., topical retinoids, hormone creams)&#xD;
                  affecting inflammation in the treatment area within 30 days of the study 3) The&#xD;
                  patient has inflammatory or infectious skin conditions or unhealed wounds in the&#xD;
                  treatment areas.&#xD;
&#xD;
                  4) The patient has a cancerous or pre-cancerous lesion and/or has had radiation&#xD;
                  exposure in the treatment area in the last 24 months.&#xD;
&#xD;
                  5) The patient has a history of anaphylaxis, multiple severe allergies, atopy, or&#xD;
                  is allergic to lidocaine or amide-based anesthetics, hyaluronic acid products,&#xD;
                  Streptococcal proteins or proteins from other gram positive organisms.&#xD;
&#xD;
                  6) The patient has a history of significant bleeding disorders. 7) The patient&#xD;
                  has scleroderma or fibrotic tissue disease. 8) The patient is female and of child&#xD;
                  bearing potential and/or is pregnant or lactating or is not using medically&#xD;
                  effective birth control, such as hormonal methods in use at least 30 days prior&#xD;
                  to implantation, or barrier methods such as a condom and spermicide in use at&#xD;
                  least 14 days prior to implantation.&#xD;
&#xD;
                  9) The patient is using a Legally Authorized Representative. 10) The patient is&#xD;
                  an employee or employee's family member of either the Study Sponsor or a Study&#xD;
                  Site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nowell Solish, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Nowell Solish</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5R3N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Westmount Institute of Plastic Surgery</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3Z1B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>September 3, 2014</results_first_submitted>
  <results_first_submitted_qc>December 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 17, 2014</results_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>soft tissue</keyword>
  <keyword>augmentation</keyword>
  <keyword>correction</keyword>
  <keyword>wrinkles</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dermal Filler - Aline HA</title>
          <description>Non-Randomized&#xD;
Aline HA: Implantable dermal filler</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dermal Filler - Aline HA</title>
          <description>Single armed study&#xD;
Aline HA: Implantable dermal filler</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.5" lower_limit="34" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Treatment Site Responses Post Procedure</title>
        <description>The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dermal Filler - Aline HA</title>
            <description>Non-Randomized&#xD;
Aline HA: Implantable dermal filler</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Treatment Site Responses Post Procedure</title>
          <description>The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.</description>
          <units>percentage of participants with any AE</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds</title>
        <description>For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).&#xD;
WSS:&#xD;
(0) - No wrinkle&#xD;
- Just perceptible wrinkle&#xD;
- Shallow wrinkle&#xD;
- Moderately deep wrinkle&#xD;
- Deep wrinkle, well-defined edges&#xD;
- Very deep wrinkle, redundant fold</description>
        <time_frame>6 months</time_frame>
        <population>Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.</population>
        <group_list>
          <group group_id="O1">
            <title>Dermal Filler - Aline HA</title>
            <description>Non-Randomized&#xD;
Aline HA: Implantable dermal filler</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds</title>
          <description>For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).&#xD;
WSS:&#xD;
(0) - No wrinkle&#xD;
- Just perceptible wrinkle&#xD;
- Shallow wrinkle&#xD;
- Moderately deep wrinkle&#xD;
- Deep wrinkle, well-defined edges&#xD;
- Very deep wrinkle, redundant fold</description>
          <population>Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Parametric testing</method>
            <param_type>Parametric Testing</param_type>
            <param_value>0.05</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS</title>
        <description>This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dermal Filler - Aline HA</title>
            <description>Non-Randomized&#xD;
Aline HA: Implantable dermal filler</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS</title>
          <description>This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>As reported by the investigator or the subject</desc>
      <group_list>
        <group group_id="E1">
          <title>Dermal Filler - Aline HA</title>
          <description>To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration Site Conditions</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ann Thomas</name_or_title>
      <organization>TauTona Group</organization>
      <phone>650-331-2461</phone>
      <email>athomas@tautonagroup.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01708213
org study id: CP 10664
nct id: NCT01708213
lead sponsor: 
has dmc: Yes
The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as
      determined by clinical assessment of treatment sites and routine tracking of adverse events.
A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA,
      for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6
      months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of Treatment Site Responses Post Procedure
time frame: 6 months
description: The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
measure: Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds
time frame: 6 months
description: For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).
WSS:
(0) - No wrinkle
- Just perceptible wrinkle
- Shallow wrinkle
- Moderately deep wrinkle
- Deep wrinkle, well-defined edges
- Very deep wrinkle, redundant fold
measure: Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS
time frame: 6 months
description: This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.
arm group label: Dermal Filler - Aline HA
arm group type: Experimental
description: Single armed study
intervention type: Device
intervention name: Aline HA
description: Implantable dermal filler
arm group label: Dermal Filler - Aline HA
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nowell Solish, MD
role: Principal Investigator
facility: 
facility: 
country: Canada
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 