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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014