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| Name | Class |
|---|---|
| Ulthera, Inc | INDUSTRY |
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To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octave System | Experimental | Single treatment of décolleté tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octave-Ultherapy treatment | Device | Micro-focused ultrasound delivered below the surface of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 | Improvement in lines and wrinkles of the décolleté were determined 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 |
|---|---|---|
| Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180 | Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as "improved" compared to baseline. | Day 180 |
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Inclusion Criteria:
- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté 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 |
|---|---|---|---|---|---|---|
| Merz Investigational Site #0010395 | Beverly Hills | California | 90210 | United States | ||
| Merz Investigational Site #0010321 |
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Of the 153 screened subjects, 54 subjects exited as screen failures and 99 subjects were enrolled to receive a single Octave-Ultherapy treatment in this study.
Subjects were recruited from 10 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octave-Ultherapy Treatment | Subjects received a single Ultherapy treatment with the Octave system on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population (SP) included all subjects who were enrolled and treated with the Octave System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Octave-Ultherapy Treatment | Subjects received a single Ultherapy treatment with the Octave system on Day 1. |
| 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 Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 | Improvement in lines and wrinkles of the décolleté were determined 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. | Intent-to-treat (ITT) population included all subjects who were enrolled. | Posted | Number | percentage of subjects | Day 90 |
|
|
From Day 1 up to end of the study (Up to Day 180)
Safety Population. The investigator reported 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 | Octave-Ultherapy Treatment | Subjects received a single Ultherapy treatment with the Octave system on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Aesthetics | +1 984-301-3095 | Aesthetic.Trials@merz.com |
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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 | Jul 22, 2021 | Sep 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2022 | Sep 20, 2023 | SAP_001.pdf |
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While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
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| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. | From Day 1 up to end of the study (Up to Day 180) |
| San Mateo |
| California |
| 92121 |
| United States |
| Merz Investigational Site #0010352 | Norwalk | Connecticut | 06851 | United States |
| Merz Investigational Site #0010416 | Miami | Florida | 33137 | United States |
| Merz Investigational Site #0010346 | Chicago | Illinois | 60611 | United States |
| Merz Investigational Site #0010439 | New York | New York | 10022 | United States |
| Merz Investigational Site #0010452 | New York | New York | 10075 | United States |
| Merz Investigational Site #0010396 | Wilmington | North Carolina | 28403 | United States |
| Merz Investigational Site #0010125 | Plano | Texas | 75093 | United States |
| Merz Investigational Site #0010392 | Spokane | Washington | 99202 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Participants |
|
|
| Secondary | Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180 | Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as "improved" compared to baseline. | ITT. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure. | Posted | Number | percentage of subjects | Day 180 |
|
|
|
| Secondary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. | Safety Population | Posted | Count of Participants | Participants | No | From Day 1 up to end of the study (Up to Day 180) |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 6 |
| 99 |
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.