NCT02700932|Unknown
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Sponsor study identifier
interventional
15
1 country
1
Study Start
January 20, 2016
Actual (reported)Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 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 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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 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.
January 20, 2016
Actual (reported)February 23, 2016
Actual (reported)March 7, 2016
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Rate of tattoo clearance
8 weeks post final treatment
Adverse event reporting
Through study completion, average of 1 year
3 wavelength tattoo treatment with picosecond laser (PicoWay)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003, 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.
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.
Eric F Bernstein, MD
Main Line Center for Laser Surgery
15 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2016
First Posted
March 7, 2016
Study Start
January 20, 2016
Actual (reported)Stretch Marks on Abdomen
Contact the study team to confirm eligibility.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 4, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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