Feasibility Study: Lifting and Tightening Neck Skin in Patients

November 22, 2017 updated by: Ulthera, Inc

Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • DeNova Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 30 to 65 years
  • Subject in good health
  • Body Mass index of less than 30
  • Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
  • Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
  • Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
  • Willingness and ability to comply with protocol requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
  • Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control

Exclusion Criteria:

  • Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
  • Has an active systemic or local skin disease that may alter wound healing
  • Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
  • Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Subjects who have previous history of submentoplasty and or rhytidectomy
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ultherapy™
Active Comparator: Group B
Subjects naïve to submentoplasty and or rhytidectomy
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ultherapy™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in submental volume
Time Frame: 90 days post-treatment
Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall improvement of the submental area
Time Frame: 90 days post-treatment
Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.
90 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Laxity

Clinical Trials on Ulthera System Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe