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The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with RF Device | Experimental | Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. |
|
| Treatment with IPL and RF Device | Experimental | Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempSure | Device | This device is an RF device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Noticed Improvement | Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported. | 12 week follow up |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Icon Treatments Only:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynosure | Westford | Massachusetts | 01886 | United States | ||
| Excellent Vision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Result | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With RF Device | Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. TempSure: This device is an RF device. |
| FG001 | Treatment With IPL and RF Device | Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. TempSure: This device is an RF device. Icon: This device works with IPL (Intense Pulsed Light) handpieces. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With RF Device | Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. TempSure: This device is an RF device. |
| BG001 | Treatment With IPL and RF Device |
| 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 Subjects Who Noticed Improvement | Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported. | Posted | Count of Participants | Participants | 12 week follow up |
|
Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.
Subjects treated in the RF + IPL device group did not have these adverse events broken down by device.
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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 RF Device | Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. TempSure: This device is an RF device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (978) 256-4200 | jamie.trimper@cynosure.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2022 | Oct 17, 2023 | Prot_SAP_000.pdf |
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One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.
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| Icon | Device | This device works with IPL (Intense Pulsed Light) handpieces. |
|
| Portsmouth |
| New Hampshire |
| 03801 |
| United States |
| Saluja Cosmetic and Laser Center | Huntersville | North Carolina | 28078 | United States |
Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. TempSure: This device is an RF device. Icon: This device works with IPL (Intense Pulsed Light) handpieces. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | Fitzpatrick Skin Type is measured on a scale from I-VI, with I representing low amounts of melanin and VI representing high amounts of melanin. Additional details can be found in the article referenced in the reference section. | Count of Participants | Participants |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Treatment With IPL and RF Device | Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. TempSure: This device is an RF device. Icon: This device works with IPL (Intense Pulsed Light) handpieces. | 0 | 35 | 0 | 35 | 5 | 35 |
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.