The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

Cupola Medical

Status: Terminated

Conditions: Tattooing

Treatments: Device: Cupola Tattoo Removal device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516034

CTR-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Treatment

Experimental group

Description:

Cupola Tattoo Removal Device

Treatment:

Device: Cupola Tattoo Removal device