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This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryo-Touch II | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryo-Touch II | Device | Percutaneous treatment with the device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Effectiveness and Safety Success |
| Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With One Point Improvement in Line Severity | • Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline | Baseline and up to 4 months |
| Participants With an Improvement in Global Appearance |
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Inclusion Criteria:
Exclusion Criteria:
Patient has any of following conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aesthetics Research Center | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 |
| 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 Effectiveness and Safety Success |
| All subjects treated were analyzed to the safety endpoint. | Posted | Number | participants | Up to 4 months |
|
|
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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 Group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francis Rogers Palmer III, MD | Myoscience | 650-474-2600 | thenry@myoscience.com |
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• Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline |
| Up to 4 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Participants With One Point Improvement in Line Severity | • Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline | Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure. | Posted | Number | participants | Baseline and up to 4 months |
|
|
|
| Secondary | Participants With an Improvement in Global Appearance | • Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline | 5 subjects were excluded from effectiveness analysis because they received a lower dose. | Posted | Number | participants | Up to 4 months |
|
|
|
| 0 |
| 41 |
| 13 |
| 41 |
| local side effect | Skin and subcutaneous tissue disorders |
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| 120 days post-treatment |
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| 90 days post-treatment |
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| 120 days post-treatment |
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