Facial Skin Laxity
Conditions
Brief summary
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
Detailed description
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.
Interventions
Ulthera® System treatment delivering focused ultrasound energy
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 30 to 65 years. * Subject in good health. * Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity. * Fitzpatrick skin phototypes of 3 through 6. * Provide 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 on the cheek. * Excessive skin laxity on the lower 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Lifting and Tightening of Treated Tissue | 90 days post treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement at 90 Days Post-treatment | 90 Days post-treatment | At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. |
| Global Aesthetic Improvement at 180 Days Post-treatment | 180 days post-treatment | At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale. |
| Patient Satisfaction Questionnaire | 90 Days post-treatment | 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 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. |
Countries
United States
Participant flow
Recruitment details
Subjects desiring lift/tightening of cheek tissue, or improved jawline definition and/or submental skin laxity, and were Fitzpatrick skin types 3-6 were recruited. Fifty-four subjects were enrolled at two facilities. Study recruitment initiated 2/16/11; follow-up concluded 1/18/12.
Pre-assignment details
Fifty-four subjects who met study eligibility requirements were assigned a study subject ID. Two subjects withdrew from the study due prior to study treatment. Data from these subjects are not included in the demographic summaries or in the efficacy analyses. Fifty-two subjects received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treated Subjects Study subjects who received a full face Ulthera treatment. (n=52) | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | Treated Subjects |
|---|---|
| Age, Continuous | 53 years |
| Fitzpatrick Skin Type Type III | 9 participants |
| Fitzpatrick Skin Type Type IV | 25 participants |
| Fitzpatrick Skin Type Type V | 15 participants |
| Fitzpatrick Skin Type Type VI | 3 participants |
| Race/Ethnicity, Customized African American/Black | 35 participants |
| Race/Ethnicity, Customized Asian | 10 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Change in Overall Lifting and Tightening of Treated Tissue
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
Time frame: 90 days post treatment
Population: Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.
Secondary
Global Aesthetic Improvement at 180 Days Post-treatment
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Time frame: 180 days post-treatment
Population: Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37.~The GAIS is 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Subjects | Global Aesthetic Improvement at 180 Days Post-treatment | PGAIS - Improved to Very Much Improved | 54.0 percentage of participants improved |
| Treated Subjects | Global Aesthetic Improvement at 180 Days Post-treatment | SGAIS - Improved to Very Much Improved | 77.0 percentage of participants improved |
Secondary
Global Aesthetic Improvement at 90 Days Post-treatment
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Time frame: 90 Days post-treatment
Population: The GAIS is 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Subjects | Global Aesthetic Improvement at 90 Days Post-treatment | PGAIS - Improved to Very Much Improved | 85.4 percentage of participants improved |
| Treated Subjects | Global Aesthetic Improvement at 90 Days Post-treatment | SGAIS - Improved to Very Much Improved | 79.2 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: 90 Days post-treatment
Population: Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated Subjects | Patient Satisfaction Questionnaire | 83.0 percentage of participants Satisfied |
Secondary
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. 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. Subjects' Yes/No responses were tabulated.
Time frame: 180 days post-treatment
Population: Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated Subjects | Patient Satisfaction Questionnaire | 72.5 percentage of participants Satisfied |
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 treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treated Subjects | Subject Assessment of Pain | Submental Region | 6 Average NRS score |
| Treated Subjects | Subject Assessment of Pain | Submandibular Region | 6 Average NRS score |
| Treated Subjects | Subject Assessment of Pain | Cheek Region | 6 Average NRS score |