Gender DysphoriaNCT04478214
The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals
An observational study of Gender Dysphoria, run by Mountain Dermatology Specialists at 1 site in United States.
Trial summary
Observational survey study of transgender individuals who have undergone cosmetic neurotoxin and soft tissue filler for the purpose of influencing gender perception. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
About this study
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
- Medical subject headings
- Gender Dysphoria
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start13 Aug 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Dermatology Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Bonati, Mountain Dermatology Specialists
- Investigators
- Lauren Bonati, MD, Principal investigator, Skin Care Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478214
- Sponsor's protocol ID
- MountainDermatology
- Status last verified
- Jul 2020
- First submitted
- 16 Aug 2019
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategic Use of Hyaluronic Acid Fillers and Neurotoxin to Influence Gender Perception in Transgender Individuals
- ClinicalTrials.gov ID
- NCT04478214
- Acronym / sponsor ID
- MountainDermatology
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mountain Dermatology SpecialistsUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational survey study of transgender individuals who have undergone cosmetic neurotoxin and soft tissue filler for the purpose of influencing gender perception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self perceived gender perception
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Bonati, MD principal investigator
Skin Care Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by Mountain Dermatology Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self perceived gender perception (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.