A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal

Cutera Inc.2 sites in 1 country27 target enrollmentOctober 2016

ConditionsTattoo Removal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tattoo Removal
Sponsor: Cutera Inc.
Enrollment: 27
Locations: 2
Primary Endpoint: Tattoo Clearing as Rated by Blinded Evaluator
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal

Detailed Description

A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

June 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cutera Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female or Male, 18 to 65 years of age (inclusive).
•Fitzpatrick Skin Type I - VI.
•Target tattoo contains single or multi-color ink, and must include blue and/or green ink.
•Target tattoos must be older than 1 year.
•Target treatment area not to exceed 12 square inches.
•Subject must be able to read, understand and sign the Informed Consent Form.
•Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
•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.
•Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
•Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).

Exclusion Criteria

•Participation in a clinical trial of a drug or another device in the target area during the study.
•Target tattoo contains only black ink.
•History of allergic reaction to pigments following tattooing.
•History of allergy to local anesthetics.
•History of allergy to topical antibiotics.
•History of malignant tumors in the target area.
•Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
•Pregnant and/or breastfeeding.
•Having an infection, dermatitis or a rash in the treatment area.
•Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.

Outcomes

Primary Outcomes

Tattoo Clearing as Rated by Blinded Evaluator

Time Frame: 6 weeks post-final treatment, approximately 7 months after study start

Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment

Secondary Outcomes

Subject Pain During Treatment(Reported by subject at the end of each treatment visit, up to 5 months)
Subject Satisfaction Levels at 6 Weeks Post-final Treatment(6 weeks post-final treatment, approximately 7 months after study start)
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).(6 weeks post-final treatment, approximately 7 months after study start)