Performance Evaluation of Tattoo Removal (NCT03866304) | Clinical Trial Compass
UnknownNot Applicable
Performance Evaluation of Tattoo Removal
Lithuania60 participantsStarted 2019-01-21
Plain-language summary
Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal
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:
* Healthy female and male subjects between 18 to 65 years of age
* Fitzpatrick Skin Type I - VI
* Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
* Have a tattoo contains containing single or multi-color ink.
* Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
* 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.
* Agree not to undergo any other procedure(s) for the tattoo removal during the study.
Exclusion Criteria:
* Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
* Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
* History of allergic reaction to pigments following tattooing.
* History of hypersensitivity to light exposure
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
* History of malignant tumors in the target area.
* Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment or during the treatment course
* Anytime in life, having have used gold therapy (gold salt…
What they're measuring
1
Tattoo clearing
Timeframe: 8 weeks post-final treatment (up to 6 month)