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The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.
This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secret RF | Other | Treatment with Secret RF for skin quality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secret RF | Device | Subjects will receive treatment with the Secret RF device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Aesthetic Improvement | Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes | at 4 weeks follow-up and 12 weeks follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ronan, MD | Cutera Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Secret RF | Treatment with Secret RF for skin quality |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Secret RF | Treatment with Secret RF for skin quality |
| 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 | Overall Aesthetic Improvement | Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes | 3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week follow up | Posted | Mean | Standard Deviation | score on a scale | at 4 weeks follow-up and 12 weeks follow-up |
|
12 weeks post final treatment, up to 8 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 | Secret RF | Treatment with Secret RF for skin quality | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2018 | Sep 12, 2023 | Prot_001.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 27 |
| 0 |
| 27 |
| 27 |
| 27 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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