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

NCT02700932 | Unknown

• 1 other identifier: DHF20901
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tattoo; Pigmentation

Keywords

non-invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of tattoo clearance

  8 weeks post final treatment

• Adverse event reporting

  Through study completion, average of 1 year

Study Arms (1)

PicoWay laser treatment

EXPERIMENTAL

3 wavelength tattoo treatment with picosecond laser (PicoWay)

Device: PicoWay

Interventions

PicoWay DEVICE

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

Also known as: PicoWayTM device

PicoWay laser treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Related Publications (2)

• 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.

  PMID: 26175187 BACKGROUND

• 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.

  PMID: 22986470 BACKGROUND

Study Officials

• Eric F Bernstein, MD

  Main Line Center for Laser Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 7, 2016
• Study Start: January 20, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

US (1)