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This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera System Treatment | Experimental | A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. |
|
| 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 |
|---|---|---|
| Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | 90 Days post-treatment |
| Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | 180 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Aesthetic Improvement at 90 Days Post-treatment | The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved |
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Inclusion Criteria:
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Any open wounds or lesions in the area.
Active and severe inflammatory acne in the region to be treated.
Patients who have a history with keloid formation or hypertrophic scarring.
Inability to understand the protocol or to give informed consent.
Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
Concurrent enrollment in any study involving the use of investigational devices or drugs.
Current smoker or history of smoking in the last one year.
History of using the following prescription medications:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Skin and Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ulthera System Treatment | A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulthera System Treatment | A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin |
| 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 | Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as 'missing' by the statistician and were not included in the denominator for the masked assessment analyses. | Posted | Number | percentage of participants | 90 Days post-treatment |
Adverse events were followed for up to 6 months post-treatment or until event resolution.
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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 System Treatment | A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| 90 days post-treatment |
| Overall Aesthetic Improvement at 180 Days Post-treatment | The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved | 180 days post-treatment |
| Subject Satisfaction at 90 Days Post-treatment | Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
"Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied | 90 days post-treatment |
| Subject Satisfaction at 180 Days Post-treatment | Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
"Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied | 180 days post-treatment |
| Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. |
| San Diego |
| California |
| 92121 |
| United States |
| Denova Research | Chicago | Illinois | 60611 | United States |
| Tennessee Research Center | Nashville | Tennessee | 37215 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Fitzpatrick's Sun-Reactive Skin Type | A classification for skin color:
| Number | participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Fabi/Bolton Score | 5-point photonumeric scale, with the following descriptors:
| Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ulthera System Treatment | A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin |
|
|
| Secondary | Overall Aesthetic Improvement at 90 Days Post-treatment | The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved | This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit. | Posted | Number | percentage of participants | 90 days post-treatment |
|
|
|
| Secondary | Overall Aesthetic Improvement at 180 Days Post-treatment | The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved | Analysis population was based the number of subjects completing a 180 day follow-up visit. | Posted | Number | percentage of participants | 180 days post-treatment |
|
|
|
| Primary | Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo. | The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects. | Posted | Number | percentage of participants | 180 days post treatment |
|
|
|
| Secondary | Subject Satisfaction at 90 Days Post-treatment | Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
"Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied | This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit. | Posted | Number | percentage of participants | 90 days post-treatment |
|
|
|
| Secondary | Subject Satisfaction at 180 Days Post-treatment | Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
"Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied | This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit. | Posted | Number | percentage of participants | 180 days post-treatment |
|
|
|
| 0 |
| 125 |
| 83 |
| 125 |
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruitus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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