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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera treatment | Device | treatment of cheeks and upper neck area of face |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90D |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90D |
| Patient Satisfaction Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Ulthera study treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M. Kenkel, MD | University of Texas Southwestern Medical Center | Principal Investigator |
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Male or Female, aged 30 to 60 years. Desire to lift and tighten cheek tissue, improve jawline definition and/or submental skin laxity.
Recruitment from June 30, 2010 to August 31, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ulthera Treatment | Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| 90D |
| COMPLETED |
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| NOT COMPLETED |
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N=33 Excluded from analysis: N=22 excluded for inclusion criteria/photo lighting/positional/makeup issues and N=11 lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulthera Treatment | Treatment to the lower face and submental region. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Average patient age | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | # of Participants |
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| 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 | 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. | 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. | Posted | Number | percentage of participants improved | 90D |
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| 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. | 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. | Posted | Number | percentage of participants improved | 90D |
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| 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. | The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available. | Posted | Number | percentage of participants improved | 90D |
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| 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. | Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed. | Posted | Mean | Full Range | Average NRS score | During Ulthera study treatment |
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Baseline, Treatment, D90, D180
Device and/or procedure related adverse events
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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 | Ulthera Treatment | Treatment to the lower face and submental region. | 0 | 103 | 0 | 103 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| Measurements |
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| Skin Type III |
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| Skin Type IV |
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| Skin Type V |
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