Skin Laxity
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed description
This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
Interventions
DEVICEUlthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sponsors
Ulthera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, age 30 to 65 years. * Subject in good health. * Skin laxity on the face and neck
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Severe solar elastosis. * Excessive subcutaneous fat in the face or neck. * Excessive skin laxity on the face or neck. * Significant scarring in areas to be treated. * Open wounds or lesions in the area to be treated. * Severe or cystic acne on the area to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Participants were assessed for the duration of study treatment, an average of 75 minutes | Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed. |
| Overall Improvement in Skin Laxity on the Face and Neck | 90 days post-treatment | A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Assessment of Brow Lift at 90 Days Post-treatment | 90 days post-treatment | Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed. |
| Subject Assessment of Improvement at 90 Days Post-treatment | 90 days post-treatment | Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck. |
| Subject Assessment of Improvement at 180 Days Post-treatment | 180 days post-treatment | Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck. |
Countries
United States
Participant flow
Recruitment details
Forty-seven subjects were enrolled, randomized, and treated. The first subject treated on 10/4/2011; the last subject treated on 2/13/12; the last follow-up was 10/11/12. Enrolled subjects were randomized to one of three study groups (Group A, B, or C).
Participants by arm
| Arm | Count |
|---|---|
| Group A Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face. | 16 |
| Group B Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face. | 15 |
| Group C Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face. | 16 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Total |
|---|---|---|---|---|
| Age, Continuous | 54 years | 55 years | 51 years | 53 years |
| Body Mass Index (BMI) | 24 kg/m^2 | 24 kg/m^2 | 24 kg/m^2 | 24 kg/m^2 |
| Fitzpatrick Skin Type Skin Type I | 0 participants | 1 participants | 0 participants | 1 participants |
| Fitzpatrick Skin Type Skin Type II | 10 participants | 5 participants | 5 participants | 20 participants |
| Fitzpatrick Skin Type Skin Type III | 6 participants | 7 participants | 10 participants | 23 participants |
| Fitzpatrick Skin Type Skin Type IV | 0 participants | 2 participants | 1 participants | 3 participants |
| Fitzpatrick Skin Type Skin Type V | 0 participants | 0 participants | 0 participants | 0 participants |
| Fitzpatrick Skin Type Skin Type VI | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 15 participants | 14 participants | 14 participants | 43 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 0 participants | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 16 participants | 15 participants | 16 participants | 47 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 14 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Overall Improvement in Skin Laxity on the Face and Neck
A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.
Time frame: 90 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Overall Improvement in Skin Laxity on the Face and Neck | 6 Participants |
| Group B | Overall Improvement in Skin Laxity on the Face and Neck | 6 Participants |
| Group C | Overall Improvement in Skin Laxity on the Face and Neck | 6 Participants |
Primary
Subjects' Assessment of Pain During Treatment With Lower Energy Settings
Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.
Time frame: Participants were assessed for the duration of study treatment, an average of 75 minutes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Standard Energy | 4.5 units on a scale |
| Group A | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Adjusted Energy | 3.7 units on a scale |
| Group B | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Standard Energy | 6.0 units on a scale |
| Group B | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Adjusted Energy | 3.7 units on a scale |
| Group C | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Standard Energy | 5.6 units on a scale |
| Group C | Subjects' Assessment of Pain During Treatment With Lower Energy Settings | Adjusted Energy | 5.9 units on a scale |
Secondary
Quantitative Assessment of Brow Lift at 90 Days Post-treatment
Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.
Time frame: 90 days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Standard Energy | 2 Participants |
| Group A | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Adjusted Energy | 2 Participants |
| Group B | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Standard Energy | 5 Participants |
| Group B | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Adjusted Energy | 3 Participants |
| Group C | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Standard Energy | 2 Participants |
| Group C | Quantitative Assessment of Brow Lift at 90 Days Post-treatment | Adjusted Energy | 6 Participants |
Secondary
Subject Assessment of Improvement at 180 Days Post-treatment
Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
Time frame: 180 days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Subject Assessment of Improvement at 180 Days Post-treatment | Adjusted Energy | 75 percentage of participants |
| Group A | Subject Assessment of Improvement at 180 Days Post-treatment | Standard Energy | 77 percentage of participants |
| Group B | Subject Assessment of Improvement at 180 Days Post-treatment | Standard Energy | 73 percentage of participants |
| Group B | Subject Assessment of Improvement at 180 Days Post-treatment | Adjusted Energy | 80 percentage of participants |
| Group C | Subject Assessment of Improvement at 180 Days Post-treatment | Standard Energy | 86 percentage of participants |
| Group C | Subject Assessment of Improvement at 180 Days Post-treatment | Adjusted Energy | 79 percentage of participants |
Secondary
Subject Assessment of Improvement at 90 Days Post-treatment
Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
Time frame: 90 days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Subject Assessment of Improvement at 90 Days Post-treatment | Standard Energy | 86 percentage of participants |
| Group A | Subject Assessment of Improvement at 90 Days Post-treatment | Adjusted Energy | 93 percentage of participants |
| Group B | Subject Assessment of Improvement at 90 Days Post-treatment | Standard Energy | 80 percentage of participants |
| Group B | Subject Assessment of Improvement at 90 Days Post-treatment | Adjusted Energy | 80 percentage of participants |
| Group C | Subject Assessment of Improvement at 90 Days Post-treatment | Standard Energy | 93 percentage of participants |
| Group C | Subject Assessment of Improvement at 90 Days Post-treatment | Adjusted Energy | 87 percentage of participants |