The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 30
Summary
- Conditions
- Tattooing
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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 wit...
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.
Tracking Information
- NCT #
- NCT01516034
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David J Friedman, M.D. Friedman Skin & Laser Center Study Director: Lilach Gavish, Ph.D. Friedman Skin & Laser Center
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