Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02700932|
Recruitment Status : Unknown
Verified April 2017 by Syneron Medical.
Recruitment status was: Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : April 4, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Tattoo; Pigmentation||Device: PicoWay||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal|
|Actual Study Start Date :||January 20, 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: PicoWay laser 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 wave length of 785±20 nm that was added to the system
Other Name: PicoWayTM device
- Global percentage of tattoo clearance [ Time Frame: 8 weeks post final treatment ]Global percentage of tattoo clearance as assessed by blinded evaluators based on comparing pre and post treatment photos.
- Rate of tattoo clearance [ Time Frame: 8 weeks post final treatment ]Average number of treatments determined to achieve 50 and 75 percent clearance
- Adverse event reporting [ Time Frame: Through study completion, average of 1 year ]Based on rate and severity of treatments with the PicoWay laser treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700932
|United States, Pennsylvania|
|Main Line Center for Laser Surgery|
|Ardmore, Pennsylvania, United States, 19003|
|Principal Investigator:||Eric F Bernstein, MD||Main Line Center for Laser Surgery|