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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 PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment.
Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay 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 proceed to the 8-weeks follow-up (FU) visit with no more treatments.
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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 wavelength of 785 nm that was added to the system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded evaluation of pigmentation clearance | Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos. | 8 weeks post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Global percentage of pigmentation clearance | Global percentage of pigmentation clearance, as assessed by study investigators based on comparing pre and post treatment photos. | 8 weeks post final treatment |
| Number of patients with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konika Schallen, MD | Contact | 508-358-7400 | konikap@syneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Konika Schallen, MD | Syneron Candela Institute for Education Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneron Candela Institute for Education Clinic | Recruiting | Wayland | Massachusetts | 01778 | 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. | |
| 26922302 | Background | Levin MK, Ng E, Bae YS, Brauer JA, Geronemus RG. Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. Lasers Surg Med. 2016 Feb;48(2):181-7. doi: 10.1002/lsm.22454. |
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|
Based on rate and severity of treatments with the PicoWay laser treatment
| Through study completion, average of 1 year |
| Investigator satisfaction with treatment | A 5-point satisfaction scale will be used by study investigators to assess satisfaction with treatment outcome | 8 weeks post final treatment |
| Subject satisfaction with treatment | A 5-point satisfaction scale will be used by subjects to assess satisfaction with treatment outcome | 8 weeks post final treatment |