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To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.
The purpose of this investigation is to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser for benign pigmented lesion (BPL) removal. Currently, the enlightenTM laser offers two wavelengths: 532nm KTP and 1064nm Nd:YAG. The version of the laser under investigation allows the user to choose from a range of wavelengths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Enlighten Device | Experimental | Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Enlighten Device | Device | Up to 3 laser treatments, spaced 4 to 6 weeks apart |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Change of Treated Lesions | Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement. | Baseline and 6 weeks post-final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject | Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied. | 6 weeks post-final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourdes Moldre, NP | Cutera Inc. | 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 | Healty Evaluation of Clinical Study | Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Group | The following types of benign pigmented lesions will be treated in this study: (1) lentigines (solar or senile); (2) ephelides (freckles); and (3) seborrheic keratosis. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants With Change of Treated Lesions | Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement. | Posted | Number | % of participants | Baseline and 6 weeks post-final treatment |
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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 | Investigational Enlighten Device | Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser. Investigational Enlighten Device: Up to 3 laser treatments, spaced 4 to 6 weeks apart |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ginger Pocock | Cutera | 4156575702 | gpocock@cutera.com |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject | Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied. | Posted | Number | % of participants | 6 weeks post-final treatment |
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| 32 |
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| 32 |
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| Title | Measurements |
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