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The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals

Sponsor
Mountain Dermatology Specialists (Other)
Overall Status
Completed
CT.gov ID
NCT04478214
Collaborator
(none)
2
Enrollment
1
Location
11.1
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational survey study of transgender individuals who have undergone cosmetic neurotoxin and soft tissue filler for the purpose of influencing gender perception.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals
    Actual Study Start Date :
    Aug 13, 2019
    Actual Primary Completion Date :
    Jul 15, 2020
    Actual Study Completion Date :
    Jul 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Self perceived gender perception [4 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male or female transgender volunteer

    • Has the desire to alter gender perception and is seeking treatment with neurotoxin and soft tissue filler

    • Subjects with an already existing treatment plan

    • Willing to sign photography release, with the understanding the de-identified photographs may be used in medical publications or presentations for the purposes of education

    • Females of childbearing potential who are sexually active are using a reliable method of contraception1 at least one month before the beginning of the study, and throughout the study

    • Must be informed about the study objectives and procedures, and be able to understand them

    • Willing and able to fulfill the study requirements and schedule

    • Willing to give their written informed consent

    Exclusion Criteria:

    • Individuals who underwent a neurotoxin procedure on the face within 6 months of study start

    • Individuals who underwent an injectable filler procedure on the face within 1 year of study start

    • Individuals who underwent surgical procedure on the face for the purpose of gender reassignment or cosmetic enhancement at any point in time before study start Individuals who have planned cosmetic treatments or surgeries during the course of the study

    • Individuals with dental procedures performed 30 days before, during, or 30 days after the course of the study

    • Individuals who participated within the 30 days before inclusion or currently participating in another clinical study involving the investigational areas

    • Individuals with known or suspected defect of healing

    • Individuals with any disease state or inappropriate physical skin condition that might impair evaluations or increase the health risk to the subject by participation in the opinion of the Investigator

    • Individuals unable to be contacted by phone in case of emergency

    • Individuals who are currently participating in any other clinical trial or have participated in any clinical trial involving the investigation area within 30 days prior to inclusion into the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Skin Care Physicians Chestnut Hill Massachusetts United States 02467

    Sponsors and Collaborators

    • Mountain Dermatology Specialists

    Investigators

    • Principal Investigator: Lauren Bonati, MD, Skin Care Physicians

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lauren Bonati, Principle Investigator, Mountain Dermatology Specialists
    ClinicalTrials.gov Identifier:
    NCT04478214
    Other Study ID Numbers:
    • MountainDermatology
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gender Dysphoria

    Study Results

    No Results Posted as of Jul 20, 2020