The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

Tattooing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01516034
• Other study ID #: CTR-2
• Status: Terminated
• Phase: N/A
• First received: January 16, 2012
• Last updated: November 22, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Cupola Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tattooing

Intervention

Device:
• Cupola Tattoo Removal device
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.

Locations

Country	Name	City	State
Israel	Dr David Friedman Laser & Skin Center, Diskin 60 st.	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Cupola Medical Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No