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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01368874
First received: June 6, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Facial and Neck Skin Laxity
Device: Ulthera® System treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]
    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.

  • Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

  • 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 ] [ Designated as safety issue: No ]

    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

  • 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 ] [ Designated as safety issue: No ]

    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

  • Patient Satisfaction 90 Days Post-treatment [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction Questionnaire 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    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.

  • L'Oreal Photographic Scale Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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).

  • L'Oreal Photographic Scale 90 Days Post-treatment [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]

    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).

  • L'Oreal Photographic Scale 180 Days Post-treatment [ Time Frame: 180 Days post-treatment ] [ Designated as safety issue: No ]

    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).


Other Outcome Measures:
  • Subjects' Assessment of Pain [ Time Frame: During Ulthera treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 71
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Ultherapy

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368874

Locations
United States, Florida
Baumann Cosmetic and Research Institute
Miami Beach, Florida, United States, 33140
United States, Minnesota
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Leslie Baumann, M.D. Baumann Cosmetic and Research Institute
Principal Investigator: Brian Zelickson, M.D. Zel Skin and Laser Specialist
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01368874     History of Changes
Other Study ID Numbers: ULT-110
Study First Received: June 6, 2011
Results First Received: June 3, 2013
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014