Clinical trial NCT01516034: The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
Official title: The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tattooing
Keywords: Tattoo removal
ultrasound
Lead sponsor: Cupola Medical Ltd
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Tattoo Removal Efficiency
timeFrame: 6 months (termination)
Secondary outcomes:
measure: Tolerability Score
timeFrame: 0, 2, 4, 6, 8, 10 weeks (after every treatment)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dr David Friedman Laser & Skin Center, Diskin 60 st.
Study officials:
affiliation: Friedman Skin & Laser Center
name: David J Friedman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedman Skin & Laser Center
name: Lilach Gavish, Ph.D.
role: STUDY_DIRECTOR
References: