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. 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
Information provided by (Responsible Party):
Cupola Medical Ltd

January 16, 2012
January 24, 2012
November 9, 2012
December 21, 2012
December 21, 2012
November 2011
November 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01516034 on Archive Site
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.
Same as current
Not Provided
Not Provided
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: Cupola Tattoo Removal device
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
Experimental: Treatment
Cupola Tattoo Removal Device
Intervention: Device: Cupola Tattoo Removal device
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Cupola Medical Ltd
Cupola Medical Ltd
Not Provided
Principal Investigator: David J Friedman, M.D. Friedman Skin & Laser Center
Study Director: Lilach Gavish, Ph.D. Friedman Skin & Laser Center
Cupola Medical Ltd
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP