Premature Jowl and Neck Laxity Following FacialplastyNCT03945422
The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty
A study testing AccuTite/FaceTite in people with Premature Jowl and Neck Laxity Following Facialplasty, run by InMode MD Ltd. at 1 site in United States.
Trial summary
Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Jowl and Neck Laxity Following Facialplasty
- What is being tested?
- AccuTite/FaceTite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 18 Jan 2021
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments.
- Lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction).
- Lack of previous Face Lift complications (no nerve injury or hematoma history).
- The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including thepermission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- The Handpiece should be used at least 1cm away from cochlear implants in the ear.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
Show all 16Show fewer
- History of bleeding coagulopathies or use of anticoagulants
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonalvirilization.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
- Allergies, in particular to anesthesia.
- Mental disorders such as Body Dysmorphic Disorder (BDD).
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Center for Facial Plastics
Chicago, Illinois, 60611
About this study
Official title: The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty
- Being tested
- AccuTite/FaceTite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuTite/FaceTiteDevice
Also called Morpheus8
Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subject will receive AccuTite/FaceTite and Morpheus8 treatment Receives: Device: AccuTite/FaceTite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin appearance
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.
Measured: 3 months, 6 month, 9 months
Secondary outcomes (3)
Investigator assessment of the skin appearance
Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement ; 0 = No difference.
Measured: 3 Month, 6 Months, 9 Months
Optional: 3D Photographic analysis
3D Photographic analysis will be conducted using QuantifiCare System
Measured: 3 months, 6 month, 9 months
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
The pictures will be sent through the system and evaluated by crowd workers.
Measured: 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start15 Apr 2019
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Jowl and Neck Laxity Following FacialplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive the treatment and outcome will be followed
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945422
- Sponsor's protocol ID
- DO608522A
- Status last verified
- Jan 2022
- First submitted
- 7 May 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
- ClinicalTrials.gov ID
- NCT03945422
- Acronym / sponsor ID
- DO608522A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 10 May 2019 (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.
Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive the treatment and outcome will be followed
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: AccuTite/FaceTiteSubject will receive AccuTite/FaceTite and Morpheus8 treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments.
- Lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction).
- Lack of previous Face Lift complications (no nerve injury or hematoma history).
- The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including thepermission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Key exclusion criteria (16 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- The Handpiece should be used at least 1cm away from cochlear implants in the ear.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuTite/FaceTiteAlso: Morpheus8Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF | Device | Treatment Arm |
Primary outcome
Change in skin appearance
Time frame: 3 months, 6 month, 9 months
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.
3 secondary outcomes
Investigator assessment of the skin appearance
Time frame: 3 Month, 6 Months, 9 Months
Optional: 3D Photographic analysis
Time frame: 3 months, 6 month, 9 months
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
Time frame: 3 Months, 6 Months
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 10 Jan 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuTite/FaceTite in people with Premature Jowl and Neck Laxity Following Facialplasty, run by InMode MD Ltd. 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 5 inclusion and 16 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 10 Jan 2022. 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?
Change in skin appearance (time frame: 3 months, 6 month, 9 months). 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 10 Jan 2022.