The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

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

Detailed Description
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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.

Official Title
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The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design

Conditions
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Tattooing

Intervention / Treatment
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* Device: Cupola Tattoo Removal device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tattoos Age of tattoo - more than 1 year since application Type - decorative (not cosmetic) Not previously treated 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: Skin conditions Skin type 5 and 6 History of keloid formation Active herpes simplex Psoriasis or vitiligo Other medical conditions HIV or Hepatitis Pregnancy or intention to become pregnant in the next 6 months No allergic reaction during the tattooing process. Medication Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive Taking isotretinoin (Accutane) currently or within the last 6 months Minocyclin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Cupola Tattoo Removal Device | Device: Cupola Tattoo Removal device<br>* Up to 6 treatments with the device every 2-3 weeks to the tattoo area.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tattoo removal, ultrasound