<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/NCT04478214</url>
  </required_header>
  <id_info>
    <org_study_id>MountainDermatology</org_study_id>
    <nct_id>NCT04478214</nct_id>
  </id_info>
  <brief_title>The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals</brief_title>
  <official_title>The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mountain Dermatology Specialists</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mountain Dermatology Specialists</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational survey study of transgender individuals who have undergone cosmetic neurotoxin&#xD;
      and soft tissue filler for the purpose of influencing gender perception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Self perceived gender perception</measure>
    <time_frame>4 weeks</time_frame>
    <description>subject reported gender perception on a novel Self-perceived gender perception scale, before and after previously conducted cosmetic treatments. The scale exists on a spectrum of 100% male to 100% female in appearance. Pt will rate themselves along this scale in accordance with their physical appearance as it relates to self-perceived gender.</description>
  </primary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Gender Dysphoria</condition>
  <eligibility>
    <study_pop>
      <textblock>
        2 healthy transgender volunteers age 18-65, of any skin type, with the desire to alter&#xD;
        gender perception, and are already scheduled for standard of care treatments will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female transgender volunteer&#xD;
&#xD;
          -  Has the desire to alter gender perception and is seeking treatment with neurotoxin and&#xD;
             soft tissue filler&#xD;
&#xD;
          -  Subjects with an already existing treatment plan&#xD;
&#xD;
          -  Willing to sign photography release, with the understanding the de-identified&#xD;
             photographs may be used in medical publications or presentations for the purposes of&#xD;
             education&#xD;
&#xD;
          -  Females of childbearing potential who are sexually active are using a reliable method&#xD;
             of contraception1 at least one month before the beginning of the study, and throughout&#xD;
             the study&#xD;
&#xD;
          -  Must be informed about the study objectives and procedures, and be able to understand&#xD;
             them&#xD;
&#xD;
          -  Willing and able to fulfill the study requirements and schedule&#xD;
&#xD;
          -  Willing to give their written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who underwent a neurotoxin procedure on the face within 6 months of study&#xD;
             start&#xD;
&#xD;
          -  Individuals who underwent an injectable filler procedure on the face within 1 year of&#xD;
             study start&#xD;
&#xD;
          -  Individuals who underwent surgical procedure on the face for the purpose of gender&#xD;
             reassignment or cosmetic enhancement at any point in time before study start&#xD;
             Individuals who have planned cosmetic treatments or surgeries during the course of the&#xD;
             study&#xD;
&#xD;
          -  Individuals with dental procedures performed 30 days before, during, or 30 days after&#xD;
             the course of the study&#xD;
&#xD;
          -  Individuals who participated within the 30 days before inclusion or currently&#xD;
             participating in another clinical study involving the investigational areas&#xD;
&#xD;
          -  Individuals with known or suspected defect of healing&#xD;
&#xD;
          -  Individuals with any disease state or inappropriate physical skin condition that might&#xD;
             impair evaluations or increase the health risk to the subject by participation in the&#xD;
             opinion of the Investigator&#xD;
&#xD;
          -  Individuals unable to be contacted by phone in case of emergency&#xD;
&#xD;
          -  Individuals who are currently participating in any other clinical trial or have&#xD;
             participated in any clinical trial involving the investigation area within 30 days&#xD;
             prior to inclusion into the 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>Lauren Bonati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin Care Physicians</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skin Care Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 16, 2019</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mountain Dermatology Specialists</investigator_affiliation>
    <investigator_full_name>Lauren Bonati</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gender Dysphoria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04478214
org study id: MountainDermatology
nct id: NCT04478214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational survey study of transgender individuals who have undergone cosmetic neurotoxin
      and soft tissue filler for the purpose of influencing gender perception.
observational model: Cohort
time perspective: Prospective
measure: Self perceived gender perception
time frame: 4 weeks
description: subject reported gender perception on a novel Self-perceived gender perception scale, before and after previously conducted cosmetic treatments. The scale exists on a spectrum of 100% male to 100% female in appearance. Pt will rate themselves along this scale in accordance with their physical appearance as it relates to self-perceived gender.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren Bonati, MD
role: Principal Investigator
affiliation: Skin Care Physicians
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mountain Dermatology Specialists
investigator full name: Lauren Bonati
investigator title: Principle Investigator
mesh term: Gender Dysphoria
sharing ipd: Undecided