The INFORM Study: Rotational Fractional Resection for Submental Contouring

Study Overview
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Brief Summary
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Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

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) 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, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Official Title
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The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Focal Contouring System


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 Agree to maintain weight (±5%) for the duration of the study Exclusion Criteria: Greater than mild submental fat 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 (RFR)<br>Single treatment of skin resection (removal of loose skin) | Device: Focal Contouring System<br>* Single treatment of skin resection (removal of loose skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Skin Laxity | Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | Pre-treatment and 90 days after treatment | 
| Subject Satisfaction: Subject Satisfaction Questionnaire | Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire | 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, laxity