A Study of a Novel Multi-Wavelength Laser for Tattoo Removal

• ClinicalTrials.gov Identifier: NCT02910505
• Recruitment Status: Unknown
• First Posted: September 22, 2016
• Last Update Posted: January 23, 2018
• Sponsor: Cutera Inc.
• Information provided by (Responsible Party): Cutera Inc.

Study Description

Brief Summary:

Single center study to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.

Condition or disease	Intervention/treatment	Phase
Tattoo Removal	Device: enLighten Laser	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: October 2016
• Estimated Primary Completion Date: June 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Treatment with investigational Cutera enlighten laser for tattoo removal	Device: enLighten Laser; Laser for tattoo removal

Outcome Measures

Primary Outcome Measures :

1. Tattoo clearing as rated by Investigator [ Time Frame: 6 weeks post-final treatment ]
   Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).

Secondary Outcome Measures :

1. Tattoo clearing as rated by Subject [ Time Frame: 6 weeks post-final treatment ]
   Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the subject (Subject's Global Assessment of Improvement).
2. Subject satisfaction Questionnaire [ Time Frame: 6 weeks post-final treatment ]
   Subject satisfaction levels at 6 weeks post-final treatment using Subject Satisfaction Assessment Scale.

Other Outcome Measures:

1. Tattoo clearing as rated by Blinded Evaluator [ Time Frame: 6 weeks post-final treatment ]
   Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers (Global Assessment of Improvement).
2. Adverse Device Effects [ Time Frame: through study completion, an average of 1 year ]
   Number and severity of adverse device effects during the study period

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.
• 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.
• 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 within 6 months of study participation.
• Anytime in life, having have 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.

Contacts and Locations

Contacts

Contact: Emily Hu; 4156575543; ehu@cutera.com

Locations

United States, Connecticut

Connecticut Skin Institute; Recruiting

Stamford, Connecticut, United States, 06905

Contact: John Liongson 203-428-4440 admin@ctskindoc.com

Sponsors and Collaborators

Cutera Inc.

Investigators

• Principal Investigator: Omar Ibrahimi, MD; Connecticut Skin Institute

More Information

• Responsible Party: Cutera Inc.
• ClinicalTrials.gov Identifier: NCT02910505
• Other Study ID Numbers: C-16-EN14
• First Posted: September 22, 2016
• Last Update Posted: January 23, 2018
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No