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| Name | Class |
|---|---|
| Ulthera, Inc | INDUSTRY |
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Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Ulthera System | Experimental |
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| Delayed-treatment Ulthera System | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultherapy treatment | Device | Focused ultrasound energy delivered below the surface of the skin |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90 | Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Displacement of Skin in the Submentum at Day 90 | Displacement of skin (in millimeters [mm]) in the submentum was determined by three-dimensional (3D) quantitative photographic analysis by comparing Day 90 photographs with baseline photographs. X-axis (lateral), Y-axis (vertical), and Z-axis (anterior to posterior) direction components were provided for both sides of the face combined (that is, overall). |
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Inclusion Criteria:
- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital, Merz Investigational Site #0860003 | Beijing | 100034 | China | |||
| Air Force General Hospital, Merz Investigational Site #0860002 |
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Of the 213 screened subjects,12 were exited as screen failures and 201 subjects were enrolled and randomized in this study.
Subjects were recruited from 5 investigational sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Ulthera DeepSEE System | Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1. |
| FG001 | Untreated Control/Delayed-treatment With Ulthera DeepSEE System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2023 | Jan 17, 2023 |
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| Untreated-control / delayed-treatment | Device | Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin) |
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| Day 90 |
| Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group | iGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the iGAIS. | Day 90 |
| Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group | sGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the sGAIS. | Day 90 |
| Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group | The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome). | Baseline up to Day 90 |
| Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs) | From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) |
| Beijing |
| 100142 |
| China |
| Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029 | Beijing | 100730 | China |
| Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015 | Shanghai | 200011 | China |
| Huashan Hospital Shanghai, Merz Investigational Site #0860004 | Shanghai | 200040 | China |
Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
| Safety Evaluation Set (SES) |
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| COMPLETED |
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| NOT COMPLETED |
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SES included all subjects who were treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Ulthera DeepSEE System | Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1. |
| BG001 | Untreated Control/Delayed-treatment With Ulthera DeepSEE System | Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90 | Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline. | The full analysis set (FAS) included all subjects randomized with baseline photographs of acceptable quality. | Posted | Number | percentage of subjects | Day 90 |
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| Secondary | Displacement of Skin in the Submentum at Day 90 | Displacement of skin (in millimeters [mm]) in the submentum was determined by three-dimensional (3D) quantitative photographic analysis by comparing Day 90 photographs with baseline photographs. X-axis (lateral), Y-axis (vertical), and Z-axis (anterior to posterior) direction components were provided for both sides of the face combined (that is, overall). | FAS. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeter (mm) | Day 90 |
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| Secondary | Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group | iGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the iGAIS. | FAS. This endpoint was pre-specified for the treatment group only. | Posted | Number | percentage of subjects | Day 90 |
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| Secondary | Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group | sGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the sGAIS. | FAS. This endpoint was pre-specified for the treatment group only. | Posted | Number | percentage of subjects | Day 90 |
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| Secondary | Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group | The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome). | FAS. This endpoint was pre-specified for the treatment group only. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Day 90 |
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| Secondary | Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs) | SES. | Posted | Count of Participants | Participants | No | From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) |
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From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)
SES. The investigator reported 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 | Treatment With Ulthera DeepSEE System | Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1 and were followed for 180 days after treatment. | 0 | 97 | 3 | 97 | 34 | 97 |
| EG001 | Untreated Control/Delayed-treatment With Ulthera DeepSEE System | Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system. Subjects were followed for 90 days after treatment. | 0 | 96 | 0 | 96 | 32 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Gastric leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Application site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Application site vesicles | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Application site discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Aesthetics | +49 69 1503 | 1 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2023 | Jan 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000096182 | Treatment Delay |
| ID | Term |
|---|---|
| D061665 | Time-to-Treatment |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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