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

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

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.

Condition or disease	Intervention/treatment	Phase
Facial and Neck Skin Laxity	Device: Ulthera® System treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck
• Study Start Date: March 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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
2. 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
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
4. 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.
5. 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.
6. 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).
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).
8. 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).

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ulthera, Inc
• ClinicalTrials.gov Identifier: NCT01368874
• Other Study ID Numbers: ULT-110
• First Posted: June 8, 2011
• Results First Posted: November 20, 2013
• Last Update Posted: December 13, 2017
• Last Verified: April 2014

Additional relevant MeSH terms:

Cutis Laxa; Skin Diseases, Genetic; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases