Tattoo Removal
Conditions
Brief summary
Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser
Detailed description
This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single or multi-color ink. Subjects will receive laser treatments, and will be followed at 6 weeks.
Interventions
DEVICECutera enlighten laser
high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal
DEVICECynoSure PicoSure 755nm laser
high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.
Sponsors
Cutera Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | 6 weeks post-final treatment, an average of 8 months from baseline | Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Treatment Full tattoo will be treated with the Cutera enlighten laser | 5 |
| Split Tattoo Treatment Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Split Tattoo Treatment | Total | Single Arm Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
Time frame: 6 weeks post-final treatment, an average of 8 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Treatment | Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | 4 score on a scale | Standard Deviation 0 |
| Split Tattoo Treatment- Enlighten | Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | 4 score on a scale | Standard Deviation 0 |
| Split Tattoo Treatment- PicoSure | Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | 4 score on a scale | Standard Deviation 0 |