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

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ClinicalTrials.gov Identifier: NCT02431104
Recruitment Status : Terminated (Sponsor terminated study.)
First Posted : April 30, 2015
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

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.

Condition or disease Intervention/treatment Phase
Laser Tattoo Removal Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
Study Start Date : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 22, 2016

Arm Intervention/treatment
Experimental: Laser Treatment
Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
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




Primary Outcome Measures :
  1. Physician's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
    Assessment of tattoo clearance by independent blinded reviewers


Secondary Outcome Measures :
  1. Subject's Global Assessment of improvement post-final treatment [ Time Frame: 3 months ]
    Assessment of tattoo clearance by subject

  2. Subject Satisfaction post-final treatment [ Time Frame: 3 months ]
    Assessment of subject satisfaction with treatment results.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02431104


Locations
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Canada, Ontario
ICLS Dermatology and Plastic Surgery
Oakville, Ontario, Canada, L6J 7W5
Sponsors and Collaborators
Cutera Inc.
Investigators
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Principal Investigator: Sheetal Sapra, MD ICLS Dermatology and Plastic Surgery

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02431104     History of Changes
Other Study ID Numbers: C-15-EN02
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided