Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect on Elastin

August 5, 2021 updated by: Candela Corporation

Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue

This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A multi-center, blinded, non-randomized, non-controlled study

Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive one (1) treatment in the submental/neck area. Participants will complete follow-up visits for clinical evaluation at Day 14, 1 Month, 3 Month, and 6 Months after the study treatment. Standard photography will be obtained at Screening to the 6 Month follow-up, and 3D photography will be obtained at Screening, Month 3, and Month 6 visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Candela Institute of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female adults between ages 21-70 years of age.
  • Desire skin laxity lift of submental and neck regions.
  • Confirmed BMI ≤ 35.
  • Subjects who can read, understand, and sign the Informed Consent Form.
  • Subjects willing and able to comply with all study requirements.
  • Fitzpatrick skin type I-VI.
  • Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS, 0=Absent (No localized submental fat evidence), 4=Extreme (Extreme submental convexity)

Exclusion Criteria:

  • Active localized or systemic infections, that may alter wound healing.
  • Immunocompromised subjects.
  • Subjects with coagulation disorder.
  • History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
  • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
  • Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4=Severe, superficial wrinkling present), or other anatomical feature for which reduction in submental fat (SMF) which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.
  • Scarring in areas to be treated.
  • Tattoos in the treatment areas to be treated.
  • Significant open facial wounds or lesions.
  • Severe or cystic acne in treatment areas.
  • Current active smoker.
  • Use of Accutane (Isotretinoin) within the past 6 months.
  • Use of topical retinoids within 48 hours.
  • Use of prescription anticoagulants.
  • Pacemaker or internal defibrillator.
  • History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin).
  • Subjects on current oral corticosteroid therapy or within the past 6 months
  • Metal implants in the treatment area.
  • In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
  • Subjects with a history of radiation therapy to the treatment area.
  • Subject has a history of allergy to lidocaine or ester-based local anesthetics.
  • Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine.
  • Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation).
  • Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator.
  • Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year.
  • Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area.
  • Subjects have undergone laser and light treatments in the treatment area over the past 3 months.
  • Subjects have undergone superficial peel or microdermabrasion within 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Group
Single Arm: All subjects will undergo treatment for skin laxity in the submentum with a Dermal and SubQ handpiece
Device: Dermal Handpiece / SubQ Handpiece
Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in submental skin laxity
Time Frame: Baseline - Day 180 (6 months post-treatment)
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 180 (post-procedure) photographs
Baseline - Day 180 (6 months post-treatment)
Occurrence, severity, and relatedness of adverse events
Time Frame: Baseline - Day 180 (6 months post-treatment)
The number and level of severity of adverse events after device treatment. An assessment will also be made to determine if the adverse event is related to the study devices and/or procedure
Baseline - Day 180 (6 months post-treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in submental skin laxity
Time Frame: Baseline - Day 90 (3 months post-treatment)
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 90 (post-procedure) photographs
Baseline - Day 90 (3 months post-treatment)
Surface Area Assessment to demonstrate percentage of participants having improvement in tissue lift (> 20mm2 in submental and neck skin laxity)
Time Frame: Baseline vs. Day 180
Change in submental and neck skin laxity via 3D photo-analysis
Baseline vs. Day 180
Subject assessment of improvement in skin laxity
Time Frame: 3 Month Follow-Up and 6 Month Follow-Up
Improvement in skin laxity scored by subject using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5=Worse)
3 Month Follow-Up and 6 Month Follow-Up
Subject satisfaction of treatment results: Subject Satisfaction scale
Time Frame: Day 14 - 6 Month Follow-Up
Using a Subject Satisfaction scale, subjects will score satisfaction of treatment results (1=Not Satisfied, 5=Very Satisfied). Lower scores will show worse outcomes and higher scores will show better outcomes.
Day 14 - 6 Month Follow-Up
Subject assessment of pain: Numerical Pain Rating Scale
Time Frame: Treatment Visit
The subjects' assessment of pain will be completed using an 11-point Numerical Pain Rating Scale (0=No pain, 10=extreme pain)
Treatment Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Candela Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Konika Patel Schallen, MD, Candela Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PFD19002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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