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

• Sponsor: Ulthera, Inc
• Information provided by (Responsible Party): Merz North America, Inc. ( Ulthera, Inc )

Tracking Information

• First Submitted Date: June 6, 2011
• First Posted Date: June 8, 2011
• Results First Submitted Date: June 3, 2013
• Results First Posted Date: November 20, 2013
• Last Update Posted Date: December 13, 2017
• Study Start Date: March 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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: 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: Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Facial and Neck Skin Laxity

Intervention

Device: Ulthera® System treatment

Single treatment of focused ultrasound energy delivered below the surface of the skin.

Other Name: Ultherapy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2013): 71
• Original Estimated Enrollment (submitted: June 7, 2011): 65
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01368874
• Other Study ID Numbers: ULT-110
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
• Study Sponsor: Ulthera, Inc
• Collaborators: Not Provided

Investigators

• 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