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The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

NCT ID: NCT01516034

Last Updated: 2012-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Tattooing

Keywords

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Tattoo removal ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Cupola Tattoo Removal Device

Group Type EXPERIMENTAL

Cupola Tattoo Removal device

Intervention Type DEVICE

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

Interventions

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Cupola Tattoo Removal device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cupola Medical Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J Friedman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friedman Skin & Laser Center

Lilach Gavish, Ph.D.

Role: STUDY_DIRECTOR

Friedman Skin & Laser Center

Locations

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

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CTR-2

Identifier Type: -

Identifier Source: org_study_id