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

NCT04478214 | Completed

• 1 other identifier: MountainDermatology
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Self perceived gender perception

  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.

  4 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

2 healthy transgender volunteers age 18-65, of any skin type, with the desire to alter gender perception, and are already scheduled for standard of care treatments will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Mountain Dermatology Specialists: lead

Study Sites (1)

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Lauren Bonati, MD

  Skin Care Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: July 20, 2020
• Study Start: August 13, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (1)