CONFORM: Rotational Fractional Resection for Submental Contouring

Not Applicable

Completed

Interventions: Device: Rotational fractional resection (1.5mm diameter device)

Brief Summary: This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Detailed Description: This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

Recruitment & Eligibility

Inclusion Criteria

Healthy male or female, at least 30 years old
Moderate submental (neck) fat
Mild to moderate submental (neck) skin laxity (loose skin)
Willing and able to provide informed consent
Willing and able to comply with all protocol requirements
Willing to limit direct sun exposure and use sunscreen for duration of the study
Agree to maintain weight for duration of the study
Willing to have photographs taken that could identify the participant

Exclusion Criteria

Previous intervention to treat submental fat or skin laxity
Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
Sensitivity to local anesthesia
Severe acne, cystic acne or acne scars on neck
Trauma of chin or neck area
Skin infection or rash on neck
Psoriasis, eczema, rosacea, or vitiligo
History of scarring
History or current symptoms of dysphagia
Chronic or persistent coughing
Body mass index (BMI) > 30
Clinically significant bleeding disorder
Anemia, kidney disease, or liver disease

Arm && Interventions

Group	Intervention	Description
Rotational fractional resection (1.5mm diameter device)	Rotational fractional resection (1.5mm diameter device)	Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2	Baseline and 90 days post treatment	This endpoint is the difference in the measurement of submental skin area (mm\^2) between Baseline and 90 days. A reduction of ≥ 20 mm\^2 denotes improvement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	90 days after treatment	Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied", "satisfied", or "very satisfied").
Number of Participants With Post-treatment Images Correctly Identified	Pre-treatment and 90 days after treatment	Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Locations (6): Aesthetx
🇺🇸
Campbell, California, United States
Roseville Facial Plastic Surgery
🇺🇸
Roseville, California, United States
Steve Yoelin, MD Medical Associates, Inc.
🇺🇸
Newport Beach, California, United States
Miami Dermatology & Laser Institute
🇺🇸
Miami, Florida, United States
DeNova Research
🇺🇸
Chicago, Illinois, United States
Sundaram Dermatology, Cosmetic & Laser Surgery Center
🇺🇸
Fairfax, Virginia, United States