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The intended use of the PicoSure device with focus lens array used in this study is to assess images to support additional marketing claims for the treatment of pigmentation and mild to moderate wrinkles.
Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face with the PicoSure device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PicoSure Device | Experimental | The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF Non-Invasive Treatment | Device | Self-controlled single-arm group using the PicoSure device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment | Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point. | 3 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| 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 | PicoSure Device | The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles. RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PicoSure Device | The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles. RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure 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 | Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment | Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point. | Posted | Number | % of photos correctly identified | 3 month follow up | photographs | photographs |
|
Adverse events were collected from up to 9 months from the baseline
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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 | PicoSure Device | The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles. RF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device. |
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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 | Apr 20, 2021 | Apr 24, 2023 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | Subjects were graded on a Fitzpatrick Skin Type scale from I-VI, with I representing a low melanin content, and VI representing a higher melanin content. This grading criteria/scale comes from the reference listed in the protocol section. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| photographs |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.