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The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01516034
Recruitment Status : Terminated (Sponsor decided that the results were not significant enough to continue.)
First Posted : January 24, 2012
Results First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Cupola Medical Ltd

Study Description
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Brief Summary:
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.

Condition or disease Intervention/treatment Phase
Tattooing Device: Cupola Tattoo Removal device Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Cupola Tattoo Removal Device
 Device: Cupola Tattoo Removal device
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.


Outcome Measures
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Primary Outcome Measures :
  1. Tattoo Removal Efficiency [ Time Frame: 6 months (termination) ]

    Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:

    1. Scoring by independent dermatologist
    2. Measuring pigment clearance using image analysis


Secondary Outcome Measures :
  1. Tolerability Score [ Time Frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Tattoos

    • Age of tattoo - more than 1 year since application
    • Type - decorative (not cosmetic)
    • Not previously treated

  2. 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 Criteria:

  1. Skin conditions

    • Skin type 5 and 6
    • History of keloid formation
    • Active herpes simplex
    • Psoriasis or vitiligo

  2. Other medical conditions

    • HIV or Hepatitis
    • Pregnancy or intention to become pregnant in the next 6 months
    • No allergic reaction during the tattooing process.

  3. Medication

    • Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
    • Taking isotretinoin (Accutane) currently or within the last 6 months
    • Minocyclin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516034


Locations
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Israel
Dr David Friedman Laser & Skin Center, Diskin 60 st.
Jerusalem, Israel
Sponsors and Collaborators
Cupola Medical Ltd
Investigators
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Principal Investigator: David J Friedman, M.D. Friedman Skin & Laser Center
Study Director: Lilach Gavish, Ph.D. Friedman Skin & Laser Center
More Information
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Responsible Party: Cupola Medical Ltd
ClinicalTrials.gov Identifier: NCT01516034    
Other Study ID Numbers: CTR-2
First Posted: January 24, 2012    Key Record Dates
Results First Posted: December 21, 2012
Last Update Posted: December 21, 2012
Last Verified: November 2012
Keywords provided by Cupola Medical Ltd:
Tattoo removal
ultrasound