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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Laser Tattoo Removal
• Intervention / Treatment: Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oakville, Ontario, Canada, L6J 7W5
      • ICLS Dermatology and Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Enlighten laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Assessment of improvement post-final treatment	Assessment of tattoo clearance by independent blinded reviewers	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Global Assessment of improvement post-final treatment	Assessment of tattoo clearance by subject	3 months
Subject Satisfaction post-final treatment	Assessment of subject satisfaction with treatment results.	3 months
Incidence and severity of adverse device effects	Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.	Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Sheetal Sapra, MD, ICLS Dermatology and Plastic Surgery

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 22, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-15-EN02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No