Safety and Efficacy Study of a New Device for Tattoo Removal
|ClinicalTrials.gov Identifier: NCT00409162|
Recruitment Status : Unknown
Verified December 2006 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
|Condition or disease||Intervention/treatment||Phase|
|Tattoo Healthy||Device: Eraser TM device, with washing fluid||Not Applicable|
The new device (Eraser TM) uses multiple needles action with a washing fluid to remove tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes (with local analgesia if needed), after which an absorptive bandage is put over the treated area for an hour and removed. Treatment may be performed using one of two washing fluids. For one of them, blood samples for material blood level will be taken before and several times after treatment. Pictures of the tattooed area being removed will be taken before and after treatment, and at each follow-up evaluation.
Follow up evaluations will be performed at 1 week, two weeks, one month and two months post treatment. Overall health and skin condition will be evaluated, and the tattoo area will be pictured. Efficacy of tattoo removal will be evaluated after two months, by visual estimation of the percent area that reacted to treatment, and the change in brightness (both evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin condition, the study treatment will be stopped (if treatment is successful), or may be repeated (up to a limit of two additional times) if the tattoo was not completely removed.
The results of tattoo removal using both washing fluids will be analyzed and compared. A result of 3 or more on the brightness change scale will be considered as a successful treatment.
Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax and AUC.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open Label, Non Randomized, First-In-Man (Feasibility) Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device|
|Study Start Date :||December 2006|
|Study Completion Date :||October 2007|
- Pigment clearance, as evaluated by image comparison on a 1-5 analog scale
- Rate of systemic and dermatologic adverse events
- Pharmacokinetic data for washing fluid (Cmax and AUC)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409162
|Contact: Ori Nesheremail@example.com|
|Research & Development Unit, Assaf-Harofeh Medical Center,|
|Zerifin, Israel, 70300|
|Principal Investigator:||Shay Efrati, MD||Assaf Harofe Medical Center|