CONFORM: Rotational Fractional Resection for Submental Contouring

Study Overview
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Brief Summary
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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
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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.

Official Title
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The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

Conditions
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Skin Laxity, Lipodystrophy

Intervention / Treatment
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* Device: Rotational fractional resection (1.5mm diameter device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotational fractional resection (1.5mm diameter device)<br>Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) | Device: Rotational fractional resection (1.5mm diameter device)<br>* Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 90 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | Pre-treatment and 90 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Submental fullness, Submental fat, Loose skin