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

Status unconfirmed · Not applicable

Conditions studied: Tattoo; Pigmentation

In brief

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

Key facts

Study ID

NCT02700932

Run by

Syneron Medical

People needed

15

Starts

2016-01-20

Expected to finish

2017-12-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Main Line Center for Laser Surgery — Ardmore, Pennsylvania, United States

Full record on ClinicalTrials.gov

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