TattooingNCT01516034
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device
A study testing Cupola Tattoo Removal device in people with Tattooing, run by Cupola Medical Ltd at 1 site in Israel.
Trial summary
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattooing
- What is being tested?
- Cupola Tattoo Removal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tattoos
- Age of tattoo - more than 1 year since application
- Type - decorative (not cosmetic)
- Not previously treated
- General
- At least 18 years of age
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- 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
Who cannot join
- Skin conditions
- Skin type 5 and 6
- History of keloid formation
- Active herpes simplex
- Psoriasis or vitiligo
- Other medical conditions
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- HIV or Hepatitis
- Pregnancy or intention to become pregnant in the next 6 months
- No allergic reaction during the tattooing process.
- Medication
- Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
- Taking isotretinoin (Accutane) currently or within the last 6 months
- Minocyclin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
Read the 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.
- Conditions
- Tattooing
- Being tested
- Cupola Tattoo Removal device
- Keywords
- Tattoo removal, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupola Tattoo Removal deviceDevice
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Cupola Tattoo Removal Device Receives: Device: Cupola Tattoo Removal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months (termination)
Secondary outcomes (1)
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.
Measured: 0, 2, 4, 6, 8, 10 weeks (after every treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Sponsor decided that the results were not significant enough to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TattooingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cupola Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Friedman, M.D., Principal investigator, Friedman Skin & Laser CenterLilach Gavish, Ph.D., Study director, Friedman Skin & Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516034
- Sponsor's protocol ID
- CTR-2
- Status last verified
- Nov 2012
- First submitted
- 16 Jan 2012
- Last updated
- 21 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
- ClinicalTrials.gov ID
- NCT01516034
- Acronym / sponsor ID
- CTR-2
- Conditions
- Tattooing
- Keywords
- Tattoo removal, ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided that the results were not significant enough to continue.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cupola Medical LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 21 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Cupola Tattoo Removal deviceCupola Tattoo Removal Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Tattoos
- General
Key exclusion criteria (13 listed)
- Skin conditions
- Other medical conditions
- Medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cupola Tattoo Removal deviceUp to 6 treatments with the device every 2-3 weeks to the tattoo area. | Device | Treatment |
Primary outcome
Tattoo Removal Efficiency
Time frame: 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
1 secondary outcome
Tolerability Score
Time frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Friedman, M.D. principal investigator
Friedman Skin & Laser Center
Lilach Gavish, Ph.D. study director
Friedman Skin & Laser Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cupola Tattoo Removal device in people with Tattooing, run by Cupola Medical Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tattoo Removal Efficiency (time frame: 6 months (termination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.