CONFORM: Rotational Fractional Resection for Submental Contouring

Recros Medica, Inc.68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity Lipodystrophy

Interventions

Rotational fractional resection (1.5mm diameter device)DEVICE

Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Aesthetx

Campbell, California, United States

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, United States

Roseville Facial Plastic Surgery

Roseville, California, United States

Miami Dermatology & Laser Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

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.

Time frame: Baseline and 90 days post treatment

Secondary Outcomes

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline

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").

Time frame: 90 days after treatment

Number of Participants With Post-treatment Images Correctly Identified

Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Time frame: Pre-treatment and 90 days after treatment

Data from ClinicalTrials.gov

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