Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal

Conditions
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Tattoo; Pigmentation

Intervention / Treatment
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* Device: PicoWay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female and male subjects between 18 to 70 years of age Fitzpatrick skin type I-VI Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them Have at least one of the following colors in the tattoo: black, green and\ or blue. Willing to receive the proposed PicoWayTM treatments and comply with all study (protocol) requirements Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked) For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) Informed consent process is completed and subject consent is signed Exclusion Criteria: Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding Hypersensitivity to light exposure Active sun tan Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course Have a history of squamous cell carcinoma or melanoma History of keloid scarring, abnormal wound healing and / or prone to bruising Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PicoWay laser treatment<br>3 wavelength tattoo treatment with picosecond laser (PicoWay) | Device: PicoWay<br>* 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<br>* Other names: PicoWayTM device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Through study completion, average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive