Safety and Efficacy Study of a New Device for Tattoo Removal (NCT00409162) | Clinical Trial Compass
UnknownNot Applicable
Safety and Efficacy Study of a New Device for Tattoo Removal
Israel30 participantsStarted 2006-12
Plain-language summary
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.
Who can participate
Age range
18 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:
* Male or female subjects 18 years or older, of any race
* Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden)
* Subjects willing to participate as evidenced by signing the written informed consent
Exclusion Criteria:
* Subject has a dermatological disease, active or latent (e.g. psoriasis)
* Subject has a known tendency for Keloid formation.
* Subject has a known tendency for skin hyperpigmentation.
* Subject is susceptible to Koebner reaction.
* Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
* Subject has known allergy to device components/ treatment fluids
* Subject has medical conditions that may be worsened by concomitant use of washing fluid, or worsened by local anesthesia materials.
* Subject is taking certain medications or topical preparations.
* Female subject who is pregnant or lactating.
* Subject participating in any other clinical study at the same time
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
Pigment clearance, as evaluated by image comparison on a 1-5 analog scale
2
Rate of systemic and dermatologic adverse events
3
Pharmacokinetic data for washing fluid (Cmax and AUC)