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To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfocused ultrasound with visualization | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfocused ultrasound with visualization | Device | Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 | Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest. | Baseline, Day 90 |
| Number of Participants With Lift in Brow Region at Day 90 | Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area. | Baseline, Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90 | Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28945618 | Result | Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181. |
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A total of 25 participants were screened, enrolled and treated in the study.
The study was conducted at 1 site in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultherapy Treatment | Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis population included all participants that were enrolled and treated with Ultherapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultherapy Treatment | Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 | Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest. | All participants enrolled and treated with Ultherapy. Only participants categorized as good candidates for photographs were included in the analysis. Good candidates for photographs was defined as those participants who had sufficient distance between the menton and neck, and enough lower face volume to allow for accurate measurements. | Posted | Count of Participants | Participants | Baseline, Day 90 |
|
Baseline up to Day 180
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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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 | Ultherapy Treatment | Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.de |
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| Baseline, Day 90 |
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 | Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | Baseline, Day 90 |
| Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90 | Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'. | Day 90 |
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180 | Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | Baseline, Day 180 |
| Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180 | Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | Baseline, Day 180 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Full Range | kilogram per square meter (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, and skin type VI = black; never burns, tans very easily | Count of Participants | Participants |
|
Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths. |
|
|
| Primary | Number of Participants With Lift in Brow Region at Day 90 | Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area. | All participants who were treated with Ultherapy were included for the assessment. The analysis included all participants who had the measurement available for brows. One participant excluded due to inability to measure brow. | Posted | Count of Participants | Participants | Baseline, Day 90 |
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|
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| Secondary | Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90 | Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | All participants who were treated with Ultherapy were included for the assessment. | Posted | Count of Participants | Participants | Baseline, Day 90 |
|
|
|
| Secondary | Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 | Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | All participants who were treated with Ultherapy were included for the assessment. | Posted | Count of Participants | Participants | Baseline, Day 90 |
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|
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| Secondary | Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90 | Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'. | All participants who were treated with Ultherapy were included for the assessment. | Posted | Count of Participants | Participants | Day 90 |
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|
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| Secondary | Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180 | Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | All participants who were treated with Ultherapy were included for the assessment. | Posted | Count of Participants | Participants | Baseline, Day 180 |
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|
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| Secondary | Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180 | Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported. | All participants who were treated with Ultherapy were included for the assessment. | Posted | Count of Participants | Participants | Baseline, Day 180 |
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| 0 |
| 25 |
| 0 |
| 25 |
| 19 |
| 25 |
| Application site edema | General disorders | Systematic Assessment |
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| Application site tenderness | General disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Application site burn | General disorders | Systematic Assessment |
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