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Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V laser at 1064 nm and 532 nm for the improvement of skin quality.
This is an open-label, prospective, study in approximately 60 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of rhytides, lentigines, pigmentation, erythema, telangiectasia, pore size and skin texture. Subjects may undergo a 2mm punch biopsy a treatment area up to 72 hours post treatment and at a designated follow-up period per Investigator discretion. Subjects will receive laser treatments. Subjects will return to the site after final study treatment for two follow-up visits: 6 and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excel V™ Laser & Micro-Lens Array Attachment | Other | Treatment with Excel V™ Laser and a Micro-Lens Array Attachment for skin quality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excel V™ Laser & Micro-Lens Array Attach | Device | Subjects will receive laser treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Effectiveness for Skin Aesthetic Improvement | Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean | 6 or 12 weeks after the final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States | ||
| Center for Dermatology and Laser Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excel V™ Laser & Micro-Lens Array Attachment | Treatment with Excel V™ Laser and a Micro-Lens Array Attachment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Excel V™ Laser & Micro-Lens Array Attachment | Treatment with Excel V™ Laser and a Micro-Lens Array Attachment |
| 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 | Study Effectiveness for Skin Aesthetic Improvement | Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean | Posted | Mean | Standard Deviation | score on a scale | 6 or 12 weeks after the final treatment |
|
12 weeks post final treatment, up to 9 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 | Excel V™ Laser & Micro-Lens Array Attachment | Treatment with Excel V™ Laser and a Micro-Lens Array Attachment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margout Doucette | Cutera | 415-656-9612 | mdoucette@cutera.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 | Sep 12, 2017 | Jul 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sacramento |
| California |
| 95819 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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