The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

Cupola Medical Ltd8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tattooing

Interventions

Cupola Tattoo Removal deviceDEVICE

Up to 6 treatments with the device every 2-3 weeks to the tattoo area.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Jerusalem, Israel

Outcomes

Primary Outcomes

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

Time frame: 6 months (termination)

Secondary Outcomes

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.

Time frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment)

Data from ClinicalTrials.gov

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