Tattoo Removal Clinical Trial
Official title:
An Open Label, Split-tattoo Study Comparing the Safety and Efficacy of the 670nm Picosecond Laser Versus the 755 nm Picosecond Laser for Tattoo Removal
Verified date | September 2023 |
Source | Cutera Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 11 |
Est. completion date | August 16, 2017 |
Est. primary completion date | August 16, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Laser Skin Solutions Jacksonville | Jacksonville Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Cutera Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
6 weeks post-final treatment, an average of 8 months from baseline |
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