<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/NCT03241563</url>
  </required_header>
  <id_info>
    <org_study_id>ATX-TRIAM-2016</org_study_id>
    <nct_id>NCT03241563</nct_id>
  </id_info>
  <brief_title>Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat</brief_title>
  <official_title>A Randomized, Double-blind Comparison Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Goldman, Butterwick, Fitzpatrick and Groff</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Goldman, Butterwick, Fitzpatrick and Groff</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The subjects and evaluating investigator will be blinded to the treatment, thus maintaining&#xD;
      double-blind status. By nature of the varying volumes of injection, the treating investigator&#xD;
      will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced&#xD;
      4 weeks apart.&#xD;
&#xD;
      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow&#xD;
      up visits will be performed 3 and 5 days after each injection session to assess for side&#xD;
      effect and tolerability profile. After the final injection session, additional follow up&#xD;
      visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be&#xD;
      recorded at baseline and at end of study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Single-site randomized, double-blind comparison trial of Kybella injections with or&#xD;
      without triamcinolone acetate for the reduction of submental fat. 20 subjects will be&#xD;
      enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella&#xD;
      injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following&#xD;
      way:&#xD;
&#xD;
        1. Kybella alone: 2 mg/cm2 of Kybella will be delivered in up to 50 injections spaced 1.0&#xD;
           cm apart at 0.2 mL/injection for a total dose of up to 100 mg of sodium deoxycholate.&#xD;
&#xD;
        2. Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of&#xD;
           40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0&#xD;
           cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate&#xD;
           using a 30 gauge (or smaller) 0.5-inch needle.&#xD;
&#xD;
      The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular&#xD;
      margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The&#xD;
      subjects and evaluating investigator will be blinded to the treatment, thus maintaining&#xD;
      double-blind status. By nature of the varying volumes of injection, the treating investigator&#xD;
      will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced&#xD;
      4 weeks apart.&#xD;
&#xD;
      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow&#xD;
      up visits will be performed 3 and 5 days after each injection session to assess for side&#xD;
      effect and tolerability profile. After the final injection session, additional follow up&#xD;
      visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be&#xD;
      recorded at baseline and at end of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat</measure>
    <time_frame>6 Months</time_frame>
    <description>evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat</measure>
    <time_frame>6 months</time_frame>
    <description>Differences in rates of edema, erythema, tenderness, and erosion/ulceration, based on blinded evaluator assessment, will be compared between subjects treated with Kybella with and without triamcinolone</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fat Reduction</condition>
  <arm_group>
    <arm_group_label>without triamcinolone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sodium Deoxycholate without triamcinolone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>with triamcinolone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sodium Deoxycholate with triamcinolone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Deoxycholate</intervention_name>
    <arm_group_label>with triamcinolone</arm_group_label>
    <arm_group_label>without triamcinolone</arm_group_label>
    <other_name>Kybella</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone</intervention_name>
    <description>Triamcinolone 40mg/ml</description>
    <arm_group_label>with triamcinolone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Females or Males in good general health age 18 - 65 years of age&#xD;
&#xD;
          -  2. Fitzpatrick skin types I-VI&#xD;
&#xD;
          -  3. Must be willing to give and sign a HIPPA form and informed consent form&#xD;
&#xD;
          -  4. Must be willing and able to comply with all study protocols and schedules&#xD;
&#xD;
          -  5. Must have submental fat graded by the investigator as 2 or 3 using the&#xD;
             Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)&#xD;
&#xD;
          -  6. Negative urine pregnancy test prior to each treatment (if applicable)&#xD;
&#xD;
          -  7. Female patients will be either of non-childbearing potential defined as: 7.1 Having&#xD;
             no uterus 7.2 No menses for at least 12 months. Or; (WOCBP) women of childbearing&#xD;
             potential must agree to use an effective method of birth control during the course of&#xD;
             the study, such as: 7.3 Oral contraceptive pill, injection, implant, patch, vaginal&#xD;
             ring, intrauterine device 7.4 Intrauterine coil 7.5 Bilateral tubal ligation 7.6&#xD;
             Barrier method used with an additional form of contraception (e.g., sponge, spermicide&#xD;
             or condom) 7.7 Abstinence (If practicing abstinence must agree to use barrier method&#xD;
             described above (7.6) if becomes sexually active) 7.8 Vasectomized partner (must agree&#xD;
             to use barrier method described above (7.6) if becomes sexually active with&#xD;
             unvasectomized partner)&#xD;
&#xD;
          -  8. Males must be willing to be clean shaven for all study visits&#xD;
&#xD;
          -  9. The patient must have had a stable weight (no fluctuation of &gt;15 pounds in a year),&#xD;
             diet, and physical activity for the previous 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the&#xD;
             trial&#xD;
&#xD;
          -  2. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a&#xD;
             systemic disease is not yet stabilized will not be considered for entry into the study&#xD;
&#xD;
          -  3. Treatment with botulinum toxin injections in the neck or chin area within 6 months&#xD;
             before randomization&#xD;
&#xD;
          -  4. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area&#xD;
&#xD;
          -  5. Significant history or current evidence of a medical, psychological or other&#xD;
             disorder that, in the investigator's opinion, would preclude enrollment into the study&#xD;
&#xD;
          -  6. An active dermatitis or open wound in the proposed treatment area&#xD;
&#xD;
          -  7. An active bacterial, fungal, or viral infection in the proposed treatment area&#xD;
&#xD;
          -  8. Pre-existing skin condition to the submental region that may confound evaluation or&#xD;
             analysis, at investigator discretion&#xD;
&#xD;
          -  9. Previously treated with subcutaneous sodium deoxycholate to the submental region&#xD;
&#xD;
          -  10. Previously treated with focused ultrasound, radiofrequency, cryolipolysis or&#xD;
             liposuction to the submental region within the previous 6 months&#xD;
&#xD;
          -  11. Any other laser, light energy device, or chemical peel treatment to the submental&#xD;
             region within the previous 3 months&#xD;
&#xD;
          -  12. Pre-existing neurological or gastrointestinal condition leading to dysphagia,&#xD;
             dysphonia or facial nerve palsy&#xD;
&#xD;
          -  13. Pre-existing medical condition other than increased submental fat that may result&#xD;
             in increased submental fullness such as but not limited to thyroid enlargement,&#xD;
             goiter, cervical lymphadenopathy etc., at investigator discretion&#xD;
&#xD;
          -  14. Must not have a planned fat reduction procedure of any variety to the submental&#xD;
             region for the duration of the study&#xD;
&#xD;
          -  15. Must not have planned significant alterations in diet or physical activity that&#xD;
             may result in significant fluctuations in weight&#xD;
&#xD;
          -  16. Current participation or participation within 30 days prior to the start of this&#xD;
             study in a drug or other investigational research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchel P Goldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DCLA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Deoxycholic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 24, 2017</submitted>
    <returned>November 28, 2017</returned>
    <submitted>February 12, 2019</submitted>
    <returned>March 5, 2019</returned>
    <submitted>April 30, 2019</submitted>
    <returned>May 21, 2019</returned>
    <submitted>August 15, 2019</submitted>
    <returned>September 4, 2019</returned>
  </pending_results>
  <!-- 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/NCT03241563
org study id: ATX-TRIAM-2016
nct id: NCT03241563
lead sponsor: 
collaborator: 
has dmc: No
The subjects and evaluating investigator will be blinded to the treatment, thus maintaining
      double-blind status. By nature of the varying volumes of injection, the treating investigator
      will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced
      4 weeks apart.

      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow
      up visits will be performed 3 and 5 days after each injection session to assess for side
      effect and tolerability profile. After the final injection session, additional follow up
      visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be
      recorded at baseline and at end of study.
This is a Single-site randomized, double-blind comparison trial of Kybella injections with or
      without triamcinolone acetate for the reduction of submental fat. 20 subjects will be
      enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella
      injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following
      way:

        1. Kybella alone: 2 mg/cm2 of Kybella will be delivered in up to 50 injections spaced 1.0
           cm apart at 0.2 mL/injection for a total dose of up to 100 mg of sodium deoxycholate.

        2. Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of
           40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0
           cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate
           using a 30 gauge (or smaller) 0.5-inch needle.

      The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular
      margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The
      subjects and evaluating investigator will be blinded to the treatment, thus maintaining
      double-blind status. By nature of the varying volumes of injection, the treating investigator
      will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced
      4 weeks apart.

      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow
      up visits will be performed 3 and 5 days after each injection session to assess for side
      effect and tolerability profile. After the final injection session, additional follow up
      visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be
      recorded at baseline and at end of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat
time frame: 6 Months
description: evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale.
measure: Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat
time frame: 6 months
description: Differences in rates of edema, erythema, tenderness, and erosion/ulceration, based on blinded evaluator assessment, will be compared between subjects treated with Kybella with and without triamcinolone
arm group label: without triamcinolone
arm group type: Active Comparator
description: sodium Deoxycholate without triamcinolone
arm group label: with triamcinolone
arm group type: Active Comparator
description: sodium Deoxycholate with triamcinolone
intervention type: Drug
intervention name: Sodium Deoxycholate
arm group label: with triamcinolone
arm group label: without triamcinolone
other name: Kybella
intervention type: Drug
intervention name: Triamcinolone
description: Triamcinolone 40mg/ml
arm group label: with triamcinolone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchel P Goldman, MD
role: Principal Investigator
affiliation: DCLA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Triamcinolone
mesh term: Deoxycholic Acid
sharing ipd: No
submitted: October 24, 2017
returned: November 28, 2017
submitted: February 12, 2019
returned: March 5, 2019
submitted: April 30, 2019
returned: May 21, 2019
submitted: August 15, 2019
returned: September 4, 2019