Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser (NCT02431104) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
Stopped: Sponsor terminated study.
Canada0Started 2015-04
Plain-language summary
A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physician's Global Assessment of improvement post-final treatment