Treatment With the Profound System for Submental Laxity

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

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.

Study Overview

• Status: Unknown
• Conditions: Submental Laxity
• Intervention / Treatment: Device: Profound System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94401
      • Premier Plastic Surgery
    • San Ramon, California, United States, 94583
      • Gladstone Clinic
  • Georgia
    • Alpharetta, Georgia, United States, 30009
      • Mark Beaty
    • Macon, Georgia, United States, 31217
      • Coliseum Health System
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Dr. Richard Gentile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects seeking laxity treatment for submental area
2. Healthy female or male subjects ages 18 to 70 years of age
3. Informed consent process completed and signed consent
4. Willing to receive the proposed Profound treatment and follow the protocol
5. For female subjects: not pregnant or lactating;
6. 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)
7. Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations

Exclusion Criteria:

1. Surgery or any other procedure for laxity in the last 6 months
2. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
3. Known allergy to lidocaine or epinephrine or antibiotics
4. Active malignancy or history of malignancy in the past 5 years
5. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
6. 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)
7. 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)
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
9. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
10. History of significant lymphatic drainage problems
11. History of cancer which required lymph node biopsy or dissection
12. 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
13. History of keloid scarring, abnormal wound healing and / or prone to bruising
14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
15. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
16. Systemic corticosteroid therapy 6 months prior to and throughout the course of the study
17. Dysplastic nevi in the area to be treated
18. 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
19. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used
20. Subjects with history of severe edema
21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: all subjects; 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; The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Principal Investigator: Mark Beaty, M.D., Beaty Facial Plastic Surgery

Publications and helpful links

General Publications

• Ruiz-Esparza J. Nonablative radiofrequency for facial and neck rejuvenation. A faster, safer, and less painful procedure based on concentrating the heat in key areas: the ThermaLift concept. J Cosmet Dermatol. 2006 Mar;5(1):68-75. doi: 10.1111/j.1473-2165.2006.00226.x.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 1, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DHF20161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided