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The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.
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 Pro laser 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.
A multicenter study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosecond Laser System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picosecond Laser system | Device | Picosecond Laser System for the Treatment of Unwanted Tattoos |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global percentage of tattoo clearance | Global percentage of tattoo clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs. | 3 months post the final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of tattoo clearance | The average number of treatments will be determined in order to obtain 50% and 75% tattoo clearance. Rate of clearance will be assessed globally independent of tattoo color and based on individual colors. | 3 months |
| 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 |
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 |
|---|---|---|---|---|---|---|
| Washington Institute of Dermatologic Laser Surgery | Washington D.C. | District of Columbia | 20005 | United States | ||
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| New York Laser and Skin Care |
| New York |
| New York |
| 10028 |
| United States |
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |