Laser Tattoo Removal
Conditions
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.
Interventions
DEVICE532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment of improvement post-final treatment | 3 months | Assessment of tattoo clearance by independent blinded reviewers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed