The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

Not Applicable

Terminated

• Conditions: Tattooing
• Interventions: Device: Cupola Tattoo Removal device

• Registration Number: NCT01516034
• Lead Sponsor: Cupola Medical Ltd

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2012-11-09
• Results First Submitted QC: 2012-11-22
• Last Update Submitted: 2012-11-22
• Results First Posted: 2012-12-21
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Cupola Tattoo Removal device	Cupola Tattoo Removal Device

Primary Outcome Measures

Name	Time	Method
Tattoo Removal Efficiency	6 months (termination)	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

Secondary Outcome Measures

Name	Time	Method
Tolerability Score	0, 2, 4, 6, 8, 10 weeks (after every treatment)	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.

Trial Locations

Locations (1)

Dr David Friedman Laser & Skin Center, Diskin 60 st.; 🇮🇱 Jerusalem, Israel