Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for … (NCT02912507) | Clinical Trial Compass
CompletedNot Applicable
Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal
United States11 participantsStarted 2016-09-09
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Ski…
What they're measuring
1
Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
Timeframe: 6 weeks post-final treatment, an average of 8 months from baseline