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

NCT ID: NCT04478214

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2020-07-15

Brief Summary

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

Conditions

Gender Dysphoria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mountain Dermatology Specialists

OTHER

Sponsor Role: lead

Responsible Party

Lauren Bonati

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren Bonati, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Care Physicians

Locations

Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

MountainDermatology

Identifier Type: -

Identifier Source: org_study_id