Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

November 16, 2017 updated by: Ulthera, Inc

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Study Type

Interventional

Enrollment (Actual)

71

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
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Baumann Cosmetic and Research Institute
    • Minnesota
      • Edina, Minnesota, United States, 55424
        • Zel Skin and Laser Specialists

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.
  • Skin laxity in the lower face and neck.
  • Willingness and ability to comply with protocol requirements and return for follow-up visits.
  • Provides written informed consent and HIPAA authorization.

Exclusion Criteria:

  • Pregnant or lactating.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the face and lower neck.
  • Excessive skin laxity on the face and neck.
  • Significant scarring in areas to be treated.
  • Significant open facial wounds or lesions.
  • Severe or cystic acne on the face.
  • Presence of a metal stent or implant in the facial area to be treated.

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.
Device: Ulthera® System treatment
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy
ACTIVE_COMPARATOR: Group B
Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
Device: Ulthera® System treatment
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy
ACTIVE_COMPARATOR: Group C
Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
Device: Ulthera® System treatment
Single treatment of 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
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
Time Frame: 90 Days post-treatment
Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.
90 Days post-treatment
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
Time Frame: 90 Days post-treatment

Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
90 Days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time Frame: 60 days post-treatment

At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse "Any Improvement" includes participants assessed in categories 1-3
60 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time Frame: 90 days post-treatment

At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse "Any Improvement" includes participants assessed in categories 1-3
90 days post-treatment
Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.
Time Frame: 180 days post-treatment

At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse "Any Improvement" includes participants assessed in categories 1-3
180 days post-treatment
Patient Satisfaction 90 Days Post-treatment
Time Frame: 90 Days post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.
90 Days post-treatment
Patient Satisfaction Questionnaire 180 Days Post-treatment
Time Frame: 180 days post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.
180 days post-treatment
L'Oreal Photographic Scale Baseline
Time Frame: Baseline

At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

  • Horizontal neck folds (Grades 0-6)
  • Neck sagging (Grades 0-7);
  • Texture (Female grades 0-5; male grades 0-7);
  • Ptosis (Female grades 0-5; males grades 0-7).
Baseline
L'Oreal Photographic Scale 90 Days Post-treatment
Time Frame: 90 Days post-treatment

At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

  • Horizontal neck folds (Grades 0-6)
  • Neck sagging (Grades 0-7);
  • Texture (Female grades 0-5; male grades 0-7);
  • Ptosis (Female grades 0-5; males grades 0-7).
90 Days post-treatment
L'Oreal Photographic Scale 180 Days Post-treatment
Time Frame: 180 Days post-treatment

At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

  • Horizontal neck folds (Grades 0-6)
  • Neck sagging (Grades 0-7);
  • Texture (Female grades 0-5; male grades 0-7);
  • Ptosis (Female grades 0-5; males grades 0-7).
180 Days post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects' Assessment of Pain
Time Frame: During Ulthera treatment
Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.
During Ulthera treatment

Collaborators and Investigators

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

Sponsor

Ulthera, Inc

Investigators

  • Principal Investigator: Brian Zelickson, M.D., Zel Skin and Laser Specialist

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

March 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-110

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.

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