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The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

This study has been terminated.
(Sponsor decided that the results were not significant enough to continue.)
Sponsor:
Information provided by (Responsible Party):
Cupola Medical Ltd
ClinicalTrials.gov Identifier:
NCT01516034
First received: January 16, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.


Condition Intervention
Tattooing
 Device: Cupola Tattoo Removal device

Study Type: Interventional
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

Further study details as provided by Cupola Medical Ltd:

Primary Outcome Measures:
  • 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:

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


Secondary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516034

Locations
Israel
Dr David Friedman Laser & Skin Center, Diskin 60 st.
Jerusalem, Israel
Sponsors and Collaborators
Cupola Medical Ltd
Investigators
Principal Investigator: David J Friedman, M.D. Friedman Skin & Laser Center
Study Director: Lilach Gavish, Ph.D. Friedman Skin & Laser Center
  More Information

No publications provided

Responsible Party: Cupola Medical Ltd
ClinicalTrials.gov Identifier: NCT01516034     History of Changes
Other Study ID Numbers: CTR-2
Study First Received: January 16, 2012
Results First Received: November 9, 2012
Last Updated: November 22, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Cupola Medical Ltd:
Tattoo removal
ultrasound

ClinicalTrials.gov processed this record on May 21, 2013