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Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser

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: NCT02431104
Recruitment Status : Terminated (Sponsor terminated study.)
First Posted : April 30, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE April 30, 2015
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
Physician's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
Assessment of tattoo clearance by independent blinded reviewers
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Subject's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
    Assessment of tattoo clearance by subject
  • Subject Satisfaction post-final treatment [ Time Frame: 3 months ]
    Assessment of subject satisfaction with treatment results.
  • Incidence and severity of adverse device effects [ Time Frame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks ]
    Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • Physician's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
    Assessment of tattoo clearance by treating physician
  • Subject's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
    Assessment of tattoo clearance by subject
  • Subject Satisfaction post-final treatment [ Time Frame: 3 months ]
    Assessment of subject satisfaction with treatment results.
  • Incidence and severity of adverse device effects [ Time Frame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks ]
    Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
Official Title  ICMJE Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
Brief Summary A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
Detailed Description This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Laser Tattoo Removal
Intervention  ICMJE Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser
Other Name: Enlighten laser
Study Arms  ICMJE Experimental: Laser Treatment
Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
Intervention: Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 22, 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fitzpatrick Skin Type I - VI
  • Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
  • Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.

Exclusion Criteria:

  • Target tattoo is 'home made' OR was obtained from an amateur artist.
  • Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
  • Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
  • History of allergic reaction to pigments following tattooing.
  • History of allergy to local anesthetics.
  • History of malignant tumors in the target area.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • Current smoker or history of smoking within 6 months of study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02431104
Other Study ID Numbers  ICMJE C-15-EN02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cutera Inc.
Study Sponsor  ICMJE Cutera Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sheetal Sapra, MD ICLS Dermatology and Plastic Surgery
PRS Account Cutera Inc.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP