Treatment With the Profound System for Submental Laxity

NCT02595216 | Unknown

• 1 other identifier: DHF20161
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Submental Laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• safety of the profound single treatment by record of the Number, severity and type of adverse events

  from day 0 until 6 months

• Investigator satisfaction

  day 0, 1, 3, and 6 months

• Subject Satisfaction

  1, 3, and 6 months

• Subject pain assessment

  day 0 (treatment)

Study Arms (1)

all subjects

EXPERIMENTAL

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

Interventions

Profound System DEVICE

The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity

all subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (5)

Premier Plastic Surgery

San Mateo, California, 94401, United States

Location

Gladstone Clinic

San Ramon, California, 94583, United States

Location

Mark Beaty

Alpharetta, Georgia, 30009, United States

Location

Coliseum Health System

Macon, Georgia, 31217, United States

Location

Dr. Richard Gentile

Boardman, Ohio, 44512, United States

Location

Related Publications (1)

• 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.

  PMID: 17173575 BACKGROUND

Study Officials

• Mark Beaty, M.D.

  Beaty Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 3, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (5)