Mild to Moderate Skin Laxity on Cheek, Mild to Moderate Skin Laxity on Upper Neck, Mild to Moderate Subcutaneous Fat on Cheek, Mild to Moderate Subcutaneous Fat on Upper Neck
Conditions
Brief summary
The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
Detailed description
The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue. The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
Interventions
DEVICEUlthera treatment
treatment of cheeks and upper neck area of face
Sponsors
University of Texas Southwestern Medical Center
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 35 to 60 years * Subject in good health * Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity
Exclusion criteria
* Pregnant or lactating * Has an active systemic or local skin disease that may alter wound healing * Severe solar elastosis * Excessive subcutaneous fat on the cheeks * Excessive skin laxity on the lower face and neck * Has significant scarring in areas to be treated * Has significant open facial wounds or lesions * Has severe or cystic acne on the face
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. | 90D | The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Submental and Neck Skin Laxity by Quantitative Analysis | 90D | The percentage of participants assessed as having an improvement in tissue lift, i.e., \>20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis. |
| Patient Satisfaction Questionnaire | 90D | Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. 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. Subjects' Yes/No responses were tabulated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessment of Pain | During Ulthera study treatment | Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region. |
Participant flow
Recruitment details
Recruitment from June 30, 2010 to August 31, 2010.
Pre-assignment details
Male or Female, aged 30 to 60 years. Desire to lift and tighten cheek tissue, improve jawline definition and/or submental skin laxity.
Participants by arm
| Arm | Count |
|---|---|
| Ulthera Treatment Treatment to the lower face and submental region. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inclusion criteria/photography quality | 22 |
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | Ulthera Treatment |
|---|---|
| Age, Continuous | 49.5 years |
| Fitzpatrick Skin Type Skin Type I | 9 # of Participants |
| Fitzpatrick Skin Type Skin Type II | 46 # of Participants |
| Fitzpatrick Skin Type Skin Type III | 12 # of Participants |
| Fitzpatrick Skin Type Skin Type IV | 2 # of Participants |
| Fitzpatrick Skin Type Skin Type V | 1 # of Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
Primary
Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.
Time frame: 90D
Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera Treatment | Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. | 68.60 percentage of participants improved |
Secondary
Change in Submental and Neck Skin Laxity by Quantitative Analysis
The percentage of participants assessed as having an improvement in tissue lift, i.e., \>20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.
Time frame: 90D
Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera Treatment | Change in Submental and Neck Skin Laxity by Quantitative Analysis | 72.9 percentage of participants improved |
Secondary
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. 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. Subjects' Yes/No responses were tabulated.
Time frame: 90D
Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera Treatment | Patient Satisfaction Questionnaire | 67 percentage of participants improved |
Other Pre-specified
Subject Assessment of Pain
Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.
Time frame: During Ulthera study treatment
Population: Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ulthera Treatment | Subject Assessment of Pain | 6.13 Average NRS score |