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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face. |
|
| Group B | Active Comparator | Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face. |
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| Group C | Active Comparator | Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera System Treatment | Device | Focused ultrasound energy delivered below the surface of the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were assessed for the duration of study treatment, an average of 75 minutes |
| 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. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Gitt, MD | Ulthera, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulthera, Inc. | Mesa | Arizona | 85210 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face. |
| FG001 | Group B | Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face. |
| FG002 | Group C | Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | units on a scale | Participants were assessed for the duration of study treatment, an average of 75 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Population | Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| 90 days post-treatment |
| 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. | 90 days post-treatment |
| 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. | 180 days post-treatment |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Fitzpatrick Skin Type | Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | Number | participants |
|
| OG001 | 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. |
| OG002 | Group C | Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included. |
|
|
| 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. | Posted | Number | Participants | 90 days post-treatment |
|
|
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| 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. | Posted | Number | Participants | 90 days post-treatment |
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|
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| 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. | Posted | Number | percentage of participants | 90 days post-treatment |
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| 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. | Posted | Number | percentage of participants | 180 days post-treatment |
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| 0 |
| 47 |
| 0 |
| 47 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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