Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT02431104
Eligibility Criteria:
Inclusion Criteria:
* Fitzpatrick Skin Type I - VI
* Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
* 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.
Exclusion Criteria:
* Target tattoo is 'home made' OR was obtained from an amateur artist.
* Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
* Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
* History of allergic reaction to pigments following tattooing.
* History of allergy to local anesthetics.
* History of malignant tumors in the target area.
* History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02431104
Study Brief:
Protocol Section:
NCT02431104