Tattoo Removal
Conditions
Keywords
Tattoo Removal, Q-switched laser, Nd:YAG laser, Nanosecond laser, Picosecond laser, Laser therapy, Tattoo, pulsed-laser, laser treatment, remove tattoo, tattoo clearing, tattoo lightening, tattoo lighten
Brief summary
The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.
Detailed description
This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks). The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.
Interventions
DEVICEPicosecond Q-switched Laser Treatment
DEVICENanosecond Q-switched Laser Treatment
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Females or Males, 18 to 65 years of age (inclusive) * Fitzpatrick Skin Type I - IV (Appendix 3) * Tattoos containing black/blue ink alone or in combination with other colors * Target tattoos older than 1 year * Presence of tattoos equal or greater than 2 square inches, not to exceed 12 square inches * 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 use hydroquinone approximately 4 weeks pre-treatment and post- treatment if required * Willingness to have digital photographs taken of the treated area * Agree not to undergo any other procedure(s) for the tattoo removal during the study * 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
Exclusion criteria
* Participation in a study of another device or drug within 6 months prior to enrollment or during the study * Prior treatment for tattoo removal in the target area, e.g., with q-switched laser, IPL, dermabrasion, electrocautery, cryotherapy * History of allergic reaction to pigments following tattooing * Presence of double tattoo in the treatment area * 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, such as tetracycline * History of herpes simplex and/or herpes zoster (shingles) * 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 within 12 months of study participation * Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area * 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 |
|---|---|---|
| Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers. | 6-weeks post-final treatment | Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment | During treatment, approximately 10 minutes | Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Picosecond and Nanosecond Q-Switched Laser Treatment Picosecond and Nanosecond Q-Switched Laser Treatment (532 nm and 1064 nm) | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Picosecond and Nanosecond Q-Switched Laser Treatment |
|---|---|
| Age, Continuous | 34 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 42 / 42 | 42 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.
Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%)
Time frame: 6-weeks post-final treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Picosecond Q-switched Laser Treatment | Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers. | 2.54 score on a scale |
| Nanosecond Q-switched Laser Treatment | Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers. | 2.17 score on a scale |
Secondary
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome
Time frame: During treatment, approximately 10 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Picosecond Q-switched Laser Treatment | Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment | 4.1 score on a scale |
| Nanosecond Q-switched Laser Treatment | Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment | 4.4 score on a scale |