The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design|
- Tattoo Removal Efficiency [ Time Frame: 6 months (termination) ] [ Designated as safety issue: No ]
Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:
- Scoring by independent dermatologist
- Measuring pigment clearance using image analysis
- Tolerability Score [ Time Frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment) ] [ Designated as safety issue: No ]The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.
|Study Start Date:||November 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Cupola Tattoo Removal Device
Device: Cupola Tattoo Removal device
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure.
This study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition.
|Dr David Friedman Laser & Skin Center, Diskin 60 st.|
|Principal Investigator:||David J Friedman, M.D.||Friedman Skin & Laser Center|
|Study Director:||Lilach Gavish, Ph.D.||Friedman Skin & Laser Center|