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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478214
• Other study ID #: MountainDermatology
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2020
• Source: Mountain Dermatology Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gender Dysphoria

Locations

Country	Name	City	State
United States	Skin Care Physicians	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mountain Dermatology Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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