Tattoo Removal
Conditions
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.
Interventions
DEVICEenLighten Laser
Laser tattoo removal treatment
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo Clearing as Rated by Blinded Evaluator | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes |
| 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 | Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment with investigational Cutera enlighten laser for tattoo removal
enLighten Laser: Laser tattoo removal treatment | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 38.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 27 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
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
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Tattoo Clearing as Rated by Blinded Evaluator | 21 Participants |
Secondary
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement). | 3.43 score on a scale | Standard Deviation 0.7 |
Secondary
Subject Pain During Treatment
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.
Time frame: Reported by subject at the end of each treatment visit, up to 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Subject Pain During Treatment | 4.2 score on a scale | Standard Deviation 2.9 |
Secondary
Subject Satisfaction Levels at 6 Weeks Post-final Treatment
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Subject Satisfaction Levels at 6 Weeks Post-final Treatment | number of subjects reporting they were extremely satisfied or satisfied with level of clearing | 9 Participants |
| Treatment | Subject Satisfaction Levels at 6 Weeks Post-final Treatment | number of subjects reporting they were neutral with level of clearing | 4 Participants |
| Treatment | Subject Satisfaction Levels at 6 Weeks Post-final Treatment | number of subjects who said they would the investigational treatment again | 11 Participants |