Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
- Conditions
- Facial and Neck Skin Laxity
- Interventions
- Device: Ulthera® System treatment
- Registration Number
- NCT01368874
- Lead Sponsor
- Ulthera, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Ulthera® System treatment Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions. Group A Ulthera® System treatment Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth. Group C Ulthera® System treatment Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.
- Primary Outcome Measures
Name Time Method Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity 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 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
Name Time Method 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. 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 1-3Improvement 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. 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 1-3Patient Satisfaction 90 Days Post-treatment 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 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 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 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 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).
Trial Locations
- Locations (2)
Baumann Cosmetic and Research Institute
🇺🇸Miami Beach, Florida, United States
Zel Skin and Laser Specialists
🇺🇸Edina, Minnesota, United States