The PREFORM Study: 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. Rotational fractional resection is used to remove loose skin and fat.

Detailed Description
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This is a prospective, single-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 moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Official Title
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The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery

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 to severe submental laxity Up to moderate submental lipodystrophy Agree to maintain weight (±5%) for the duration of the study 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 Severe acne, cystic acne or acne scars on neck Trauma of chin or neck area Skin infection or rash on neck Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo History of scarring 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 with and without focal lipectomy (removal of loose skin and fat) | Device: Rotational fractional resection (1.5mm Diameter Device)<br>* Single treatment of skin resection and with and without 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 Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale | Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | 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 post treatment | 
| Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale | Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | 90 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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submental, laxity, lipodystrophy