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

April 3, 2017 updated by: Syneron Medical

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Ardmore, Pennsylvania, United States, 19003
        • Main Line Center for Laser Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy female and male subjects between 18 to 70 years of age
  2. Fitzpatrick skin type I-VI
  3. Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
  4. Have at least one of the following colors in the tattoo: black, green and\ or blue.
  5. Willing to receive the proposed PicoWayTM treatments and comply with all study (protocol) requirements
  6. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
  7. 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)
  8. Informed consent process is completed and subject consent is signed

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
  2. Hypersensitivity to light exposure
  3. Active sun tan
  4. 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
  5. Have a history of squamous cell carcinoma or melanoma
  6. History of keloid scarring, abnormal wound healing and / or prone to bruising
  7. 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.
  8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
  9. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
  10. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PicoWay laser treatment
3 wavelength tattoo treatment with picosecond laser (PicoWay)
Device: 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 Names:
  • PicoWayTM device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks post final treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tattoo clearance
Time Frame: 8 weeks post final treatment
Average number of treatments determined to achieve 50 and 75 percent clearance
8 weeks post final treatment
Adverse event reporting
Time Frame: Through study completion, average of 1 year
Based on rate and severity of treatments with the PicoWay laser treatment
Through study completion, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syneron Medical

Investigators

  • Principal Investigator: Eric F Bernstein, MD, Main Line Center for Laser Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DHF20901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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