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.

Study Overview

• Status: Terminated
• Conditions: Tattooing
• Intervention / Treatment: Device: Cupola Tattoo Removal device

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Dr David Friedman Laser & Skin Center, Diskin 60 st.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo Removal Efficiency	Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit: Scoring by independent dermatologist; Measuring pigment clearance using image analysis	6 months (termination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability Score	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.	0, 2, 4, 6, 8, 10 weeks (after every treatment)

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 16, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: November 22, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: ultrasound; Tattoo removal
• Other Study ID Numbers: CTR-2