June 6, 2011
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June 8, 2011
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June 3, 2013
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November 20, 2013
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December 13, 2017
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March 2011
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October 2011 (Final data collection date for primary outcome measure)
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- 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.
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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.
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- 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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - 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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - 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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - 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).
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Not Provided
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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.
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Not Provided
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Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
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Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck
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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.
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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.
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Interventional
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Not Applicable
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Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment
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Facial and Neck Skin Laxity
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Device: Ulthera® System treatment
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy
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- 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
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Not Provided
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Completed
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71
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65
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January 2012
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October 2011 (Final data collection date for primary outcome measure)
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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.
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Sexes Eligible for Study: |
All |
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30 Years to 65 Years (Adult, Older Adult)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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United States
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NCT01368874
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ULT-110
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No
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Not Provided
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Not Provided
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Merz North America, Inc. ( Ulthera, Inc )
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Ulthera, Inc
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Not Provided
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Principal Investigator: |
Leslie Baumann, M.D. |
Baumann Cosmetic and Research Institute |
Principal Investigator: |
Brian Zelickson, M.D. |
Zel Skin and Laser Specialist |
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Merz North America, Inc.
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April 2014
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