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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700932
Recruitment Status : Unknown
Verified April 2017 by Syneron Medical.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

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


Condition or disease Intervention/treatment Phase
Tattoo; Pigmentation Device: PicoWay Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
Actual Study Start Date : January 20, 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

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 Name: PicoWayTM device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of tattoo clearance [ Time Frame: 8 weeks post final treatment ]
    Average number of treatments determined to achieve 50 and 75 percent clearance

  2. Adverse event reporting [ Time Frame: Through study completion, average of 1 year ]
    Based on rate and severity of treatments with the PicoWay laser treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700932


Locations
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United States, Pennsylvania
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States, 19003
Sponsors and Collaborators
Syneron Medical
Investigators
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Principal Investigator: Eric F Bernstein, MD Main Line Center for Laser Surgery
Publications:
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Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02700932    
Other Study ID Numbers: DHF20901
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Syneron Medical:
non-invasive