Treatment With the Profound System for Submental Laxity

Study Overview
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Brief Summary
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Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment. Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol.

Detailed Description
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This study is a Prospective clinical study to evaluate the Profound device for submental laxity. Up to a total of 60 healthy candidates, seeking treatment for submental laxity. Subjects will receive one Profound treatment targeted to both dermal and subcutaneous layer of the skin. Before treatment (15-20 minutes) the tissue to be treated will be injected with tumescence solution. Each subject will be followed for additional four (4) post treatment visits

Official Title
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Clinical Study to Evaluate the Performance of Profound System With Nominal Angle of 75° to the Skin's Surface for Submental Laxity

Conditions
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Submental Laxity

Intervention / Treatment
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* Device: Profound System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects seeking laxity treatment for submental area Healthy female or male subjects ages 18 to 70 years of age Informed consent process completed and signed consent Willing to receive the proposed Profound treatment and follow the protocol For female subjects: not pregnant or lactating; either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations Exclusion Criteria: Surgery or any other procedure for laxity in the last 6 months Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding Known allergy to lidocaine or epinephrine or antibiotics Active malignancy or history of malignancy in the past 5 years Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process) Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion) History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen History of significant lymphatic drainage problems History of cancer which required lymph node biopsy or dissection Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course History of keloid scarring, abnormal wound healing and / or prone to bruising History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders Use of isotretinoin (Accutane®) within 6 months of treatment or during the study Systemic corticosteroid therapy 6 months prior to and throughout the course of the study Dysplastic nevi in the area to be treated Participation in a study of another device or drug within 3 month prior to enrollment or during this study, if treatments of wrinkles or laxity were involved Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used Subjects with history of severe edema As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: all subjects<br>All subjects in this study will receive a single Profound system treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment. Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol. | Device: Profound System<br>* The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Performance of Profound system to the skin's surface for submental laxity | using Fitzpatrick Wrinkle and Alexiades-Armenakas Laxity Scales | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of the profound single treatment by record of the Number, severity and type of adverse events | Number, severity and type of adverse events recorded | from day 0 until 6 months | 
| Investigator satisfaction | assessed by Investigator | day 0, 1, 3, and 6 months | 
| Subject Satisfaction | by Subject questionnaire | 1, 3, and 6 months | 
| Subject pain assessment | using Numerical Scale Response (NSR) | day 0 (treatment) |