Multi-Wavelength Laser Tattoo Removal Pivotal Study

NCT02935660 | Completed Results

• 1 other identifier: C-16-EN13
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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

Conditions

Tattoo Removal

Outcome Measures

Primary Outcomes (1)

• Tattoo Clearing as Rated by Blinded Evaluator

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

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

Secondary Outcomes (3)

• 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

• Subject Satisfaction Levels at 6 Weeks Post-final Treatment

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

• Subject Pain During Treatment

  Reported by subject at the end of each treatment visit, up to 5 months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with investigational Cutera enlighten laser for tattoo removal

Device: enLighten Laser

Interventions

enLighten Laser DEVICE

Laser tattoo removal treatment

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study.

You may not qualify if:

• 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.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications per investigator's discretion.
• History of vitiligo, eczema, or psoriasis.
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Cutera Research Clinic

Brisbane, California, 94005, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 17, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)