Multi-Wavelength Laser Tattoo Removal Pivotal Study

NCT ID: NCT02935660

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-06-30

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.

Conditions

Tattoo Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Treatment with investigational Cutera enlighten laser for tattoo removal

Group Type: EXPERIMENTAL

enLighten Laser

Intervention Type: DEVICE

Laser tattoo removal treatment

Interventions

enLighten Laser

Laser tattoo removal treatment

Intervention Type: DEVICE

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).
• 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.

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.
• 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.
• History of seizure disorders due to light.
• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Systemic use of corticosteroid or isotretinoin, as applicable, within 6 months of study participation.
• Anytime in life, having used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• 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.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cutera Research Clinic

Brisbane, California, United States

Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-16-EN13

Identifier Type: -

Identifier Source: org_study_id