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This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064 nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWayTM device for tattoo removal.
Up to a total of 60 healthy candidates who are seeking tattoo removal clearance treatment from participating investigators will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWayTM treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or to be forwarded to the 8 weeks Follow-Up visit with no more treatments. Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment.
Each subject will be followed at one post treatment visit that will be conducted at:
• Eight weeks post last treatment - 8wk FU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PicoWay laser treatment | Experimental | 3 wavelength tattoo treatment with picosecond laser (PicoWay) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoWay | Device | solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wave length of 785±20 nm that was added to the system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global percentage of tattoo clearance | Global percentage of tattoo clearance as assessed by blinded evaluators based on comparing pre and post treatment photos. | 8 weeks post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of tattoo clearance | Average number of treatments determined to achieve 50 and 75 percent clearance | 8 weeks post final treatment |
| Adverse event reporting | Based on rate and severity of treatments with the PicoWay laser treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric F Bernstein, MD | Main Line Center for Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26175187 | Background | Bernstein EF, Schomacker KT, Basilavecchio LD, Plugis JM, Bhawalkar JD. A novel dual-wavelength, Nd:YAG, picosecond-domain laser safely and effectively removes multicolor tattoos. Lasers Surg Med. 2015 Sep;47(7):542-548. doi: 10.1002/lsm.22391. Epub 2015 Jul 14. | |
| 22986470 | Background | Saedi N, Metelitsa A, Petrell K, Arndt KA, Dover JS. Treatment of tattoos with a picosecond alexandrite laser: a prospective trial. Arch Dermatol. 2012 Dec;148(12):1360-3. doi: 10.1001/archdermatol.2012.2894. |
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|
| Through study completion, average of 1 year |