Clinical trial NCT02431104: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
Official title: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laser Tattoo Removal
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Physician's Global Assessment of improvement post-final treatment
timeFrame: 3 months
Secondary outcomes:
measure: Subject's Global Assessment of improvement post-final treatment
timeFrame: 3 months
measure: Subject Satisfaction post-final treatment
timeFrame: 3 months
measure: Incidence and severity of adverse device effects
timeFrame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: ICLS Dermatology and Plastic Surgery
state: Ontario
Study officials:
affiliation: ICLS Dermatology and Plastic Surgery
name: Sheetal Sapra, MD
role: PRINCIPAL_INVESTIGATOR
References: