Back to resultsLifting and Tightening of the Face and Neck Utilizing the Ulthera® System
Primary Purpose
Facial and Neck Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System treatment
Sponsored by
About this trial
This is an interventional treatment trial for Facial and Neck Skin Laxity
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.
Sites / Locations
- Baumann Cosmetic and Research Institute
- Zel Skin and Laser Specialists
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.
Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
Outcomes
Primary Outcome Measures
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
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
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.
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.
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.
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
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
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
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01368874
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial and Neck Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
Intervention Type
Device
Intervention Name(s)
Ulthera® System treatment
Other Intervention Name(s)
Ultherapy
Intervention Description
Single treatment of focused ultrasound energy delivered below the surface of the skin.
Primary Outcome Measure Information:
Title
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity
Description
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.
Time Frame
90 Days post-treatment
Title
Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP
Description
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.
Time Frame
90 Days post-treatment
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
60 days post-treatment
Title
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.
Description
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
Time Frame
90 days post-treatment
Title
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.
Description
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
Time Frame
180 days post-treatment
Title
Patient Satisfaction 90 Days Post-treatment
Description
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.
Time Frame
90 Days post-treatment
Title
Patient Satisfaction Questionnaire 180 Days Post-treatment
Description
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.
Time Frame
180 days post-treatment
Title
L'Oreal Photographic Scale Baseline
Description
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).
Time Frame
Baseline
Title
L'Oreal Photographic Scale 90 Days Post-treatment
Description
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).
Time Frame
90 Days post-treatment
Title
L'Oreal Photographic Scale 180 Days Post-treatment
Description
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).
Time Frame
180 Days post-treatment
Other Pre-specified Outcome Measures:
Title
Subjects' Assessment of Pain
Description
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.
Time Frame
During Ulthera treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Baumann, M.D.
Organizational Affiliation
Baumann Cosmetic and Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Zelickson, M.D.
Organizational Affiliation
Zel Skin and Laser Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baumann Cosmetic and Research Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Zel Skin and Laser Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
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