NCT02891239|Unknown
785nm Picosecond Laser for Treatment of Benign Pigmented Lesions
Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions
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Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions
Sponsor study identifier
interventional
60
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 1, 2016
Actual (reported)September 7, 2016
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Global percentage of pigmentation clearance
8 weeks post final treatment
Number of patients with adverse events
Through study completion, average of 1 year
Investigator satisfaction with treatment
8 weeks post final treatment
Subject satisfaction with treatment
8 weeks post final treatment
3 wavelength tattoo treatment with picosecond laser (PicoWay)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, 01778, United States
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.
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.
Konika Schallen, MD
Syneron Candela Institute for Education Clinic
First Submitted
September 1, 2016
First Posted
September 7, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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