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The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosecond Laser System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GentleMax system | Device | Picosecond Laser System for the Treatment of Pigmented Lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global percentage of pigment clearance | Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs. | 3 months post the final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Adverse events will be evaluated immediately after and before each subsequent laser treatment and will be based on the incidence and severity of side effects caused by the laser treatments. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shlomit Mann | Syneron Medical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Cosmetic Dermatology | San Francisco | California | 94115 | United States | ||
| Hong Kong Dermatology and Laser Centre |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hong Kong |
| China |