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

Cutera

Status

Withdrawn

Conditions

Laser Tattoo Removal

Treatments

Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT02431104

C-15-EN02

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.