Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

NCT02832674 | Completed Results

• 1 other identifier: THERMI_0005
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits. All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters. Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Tissue Lift at the Submental Area Measuring >/= 20 mm2

  A \>/= 20 mm\^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).

  Change from baseline at Day 90

Secondary Outcomes (5)

• Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer

  Change from baseline to Days 90 and 180

• Physician Global Aesthetic Improvement Scale (P-GAIS)

  Change from baseline at Days 90 and 180

• Subject Global Aesthetic Improvement Scale (S-GAIS)

  Change from baseline at Days 90 and 180

• Physician Global Satisfaction Questionnaire (P-GSQ)

  Change from baseline at Days 90 and 180

• Subject Global Satisfaction Questionnaire (S-GSQ)

  Change from baseline at Days 90 and 180

Study Arms (1)

Single Treatment

EXPERIMENTAL

All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment'

Device: Percutaneous Radiofrequency single treatment

Interventions

Percutaneous Radiofrequency single treatment DEVICE

Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.

Also known as: Thermi Percutaneous Radiofrequency Treatment, Hunsted Infusion on the treatment area, Thermal Camera, Ice packs

Single Treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the age of 35 and 65 inclusive;
• Mild to Moderate Skin Laxity Severity on the submental area defined as: "normal" muscle, "mild to moderate" skin laxity and "mild to moderate" fat;
• Desire to improve jawline definitions and/or submental skin lift
• Body mass index (BMI) ≤30;
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Cooperative, reliable, and able to read and comprehend English;
• Able to read, understand, sign and date the informed consent document (English only);
• Able and willing to comply with the schedule visit(s) and study requirements.

You may not qualify if:

• Excessive subcutaneous fat on the submental area
• Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia);
• History of cosmetic treatments on the face and neck including but not limited to: facial skin tightening procedures within the past year, injectable fillers of any type, Botox on the lower face, ablative resurfacing laser treatment, none ablative, rejuvenative laser or light treatment within the past six months, deep facial peels, dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or other.
• History or current injury to the Head and Neck.
• Severe solar elastosis
• Clinically significant facial wounds, lesions or acute infections including cystic acne, dermatitis, lupus or other immunodeficiency affecting the dermis
• Presence of metal stents or facial implants
• Pregnant or planning pregnancy prior to the end of study participation
• Current or past history of smoking
• History or current diagnosis of cancer of any type
• History of uncontrolled cardiovascular disease(i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
• Known hypersensitivity to local anesthetic medications
• History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
• Possesses a surgically implanted electronic device (i.e. pacemaker)
• History of AIDs/HIV

Sponsors & Collaborators

• ThermiGen, LLC: lead

Study Sites (1)

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Toni Fournier, Sr. VP New Products
• Organization: ThermiGen LLC

TFournier@Thermi.com

214-888-0634

Study Officials

• Barry DiBernardo, MD

  New Jersey Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Toni Fournier

  ThermiGen, LLC

  STUDY DIRECTOR

• Kevin O'Brien

  ThermiGen, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 14, 2016
• Study Start: June 25, 2016
• Primary Completion: February 20, 2017
• Study Completion: April 8, 2017
• Last Updated: May 1, 2018
• Results First Posted: May 1, 2018

Record last verified: 2016-07

Locations

US (1)