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

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ClinicalTrials.gov Identifier: NCT01368874
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : November 20, 2013
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Tracking Information
First Submitted Date  ICMJE June 6, 2011
First Posted Date  ICMJE June 8, 2011
Results First Submitted Date  ICMJE June 3, 2013
Results First Posted Date  ICMJE November 20, 2013
Last Update Posted Date December 13, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
Overall improvement in lifting and tightening of skin [ Time Frame: 90 days compared to baseline ]
Improvement of overall lifting and tightening of skin determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Change History Complete list of historical versions of study NCT01368874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
Official Title  ICMJE Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Facial and Neck Skin Laxity
Intervention  ICMJE Device: Ulthera® System treatment
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy
Study Arms  ICMJE
  • 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.
    Intervention: Device: Ulthera® System treatment
  • Active Comparator: Group B
    Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
    Intervention: Device: Ulthera® System treatment
  • Active Comparator: Group C
    Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
    Intervention: Device: Ulthera® System treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2013)
71
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2011)
65
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01368874
Other Study ID Numbers  ICMJE ULT-110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz North America, Inc. ( Ulthera, Inc )
Study Sponsor  ICMJE Ulthera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leslie Baumann, M.D. Baumann Cosmetic and Research Institute
Principal Investigator: Brian Zelickson, M.D. Zel Skin and Laser Specialist
PRS Account Merz North America, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP