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

Syneron Medical

Status

Unknown

Conditions

Tattoo; Pigmentation

Treatments

Device: PicoWay

Study type

Interventional

Funder types

Industry

Identifiers

NCT02700932

DHF20901

Details and patient eligibility

About

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

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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