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

Not Applicable

Withdrawn

• Conditions: Laser Tattoo Removal

• Registration Number: NCT02431104
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-30
• Primary Completion: 2016-02
• Study Completion: 2016-02-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Physician's Global Assessment of improvement post-final treatment	3 months	Assessment of tattoo clearance by independent blinded reviewers

Secondary Outcome Measures

Name	Time	Method
Subject's Global Assessment of improvement post-final treatment	3 months	Assessment of tattoo clearance by subject
Subject Satisfaction post-final treatment	3 months	Assessment of subject satisfaction with treatment results.
Incidence and severity of adverse device effects	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.

Trial Locations

Locations (1)

ICLS Dermatology and Plastic Surgery; 🇨🇦 Oakville, Ontario, Canada