Status:
TERMINATED
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
Lead Sponsor:
Cupola Medical Ltd
Conditions:
Tattooing
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
Detailed 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 Helsink...
Eligibility Criteria
Inclusion
- Tattoos
- Age of tattoo - more than 1 year since application
- Type - decorative (not cosmetic)
- Not previously treated
- General
- At least 18 years of age
- Agrees to sign the Informed Consent
- Willingness to remove tattoo
- Willingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications
- Willingness to follow the treatment schedule and post treatment care requirement for tattooing and removal
- Not planning to remove the tattoo in a different procedure during the time of the experiment
Exclusion
- Skin conditions
- Skin type 5 and 6
- History of keloid formation
- Active herpes simplex
- Psoriasis or vitiligo
- Other medical conditions
- HIV or Hepatitis
- Pregnancy or intention to become pregnant in the next 6 months
- No allergic reaction during the tattooing process.
- Medication
- Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
- Taking isotretinoin (Accutane) currently or within the last 6 months
- Minocyclin
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01516034
Start Date
November 1 2011
End Date
November 1 2012
Last Update
December 21 2012
Active Locations (1)
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1
Dr David Friedman Laser & Skin Center, Diskin 60 st.
Jerusalem, Israel