TattooNCT00409162
Safety and Efficacy Study of a New Device for Tattoo Removal
A study testing Eraser TM device, with washing fluid in people with Tattoo and Healthy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Eraser TM device, with washing fluid
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years or older, of any race
- Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden)
- Subjects willing to participate as evidenced by signing the written informed consent
Who cannot join
- Subject has a dermatological disease, active or latent (e.g. psoriasis)
- Subject has a known tendency for Keloid formation.
- Subject has a known tendency for skin hyperpigmentation.
- Subject is susceptible to Koebner reaction.
- Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
- Subject has known allergy to device components/ treatment fluids
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- Subject has medical conditions that may be worsened by concomitant use of washing fluid, or worsened by local anesthesia materials.
- Subject is taking certain medications or topical preparations.
- Female subject who is pregnant or lactating.
- Subject participating in any other clinical study at the same time
Trial locations and contacts
1 site in 1 country.
Israel1 site
Research & Development Unit, Assaf-Harofeh Medical Center,
Tsrifin, 70300
About this study
Official title: A Prospective, Open Label, Non Randomized, First-In-Man (Feasibility) Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.
Read the detailed description
The new device (Eraser TM) uses multiple needles action with a washing fluid to remove tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes (with local analgesia if needed), after which an absorptive bandage is put over the treated area for an hour and removed. Treatment may be performed using one of two washing fluids. For one of them, blood samples for material blood level will be taken before and several times after treatment. Pictures of the tattooed area being removed will be taken before and after treatment, and at each follow-up evaluation.
Follow up evaluations will be performed at 1 week, two weeks, one month and two months post treatment. Overall health and skin condition will be evaluated, and the tattoo area will be pictured. Efficacy of tattoo removal will be evaluated after two months, by visual estimation of the percent area that reacted to treatment, and the change in brightness (both evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin condition, the study treatment will be stopped (if treatment is successful), or may be repeated (up to a limit of two additional times) if the tattoo was not completely removed.
The results of tattoo removal using both washing fluids will be analyzed and compared. A result of 3 or more on the brightness change scale will be considered as a successful treatment.
Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax and AUC.
- Being tested
- Eraser TM device, with washing fluid
- Keywords
- Tattoo removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eraser TM device, with washing fluidDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigment clearance, as evaluated by image comparison on a 1-5 analog scale
Rate of systemic and dermatologic adverse events
Pharmacokinetic data for washing fluid (Cmax and AUC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Hawk Medical Technologies Ltd.
- Investigators
- Shay Efrati, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409162
- Sponsor's protocol ID
- HTA 3722; 91/06
- Other IDs
- HM-AHR-1 Rev. 02
- Status last verified
- Dec 2006
- First submitted
- 7 Dec 2006
- Last updated
- 8 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Non Randomized, First-In-Man (Feasibility) Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
- ClinicalTrials.gov ID
- NCT00409162
- Acronym / sponsor ID
- HTA 3722; 91/06
- Keywords
- Tattoo removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Hawk Medical Technologies Ltd.
- Study start
- Dec 2006
- Study completion
- Oct 2007
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.
Detailed description
The new device (Eraser TM) uses multiple needles action with a washing fluid to remove tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes (with local analgesia if needed), after which an absorptive bandage is put over the treated area for an hour and removed. Treatment may be performed using one of two washing fluids. For one of them, blood samples for material blood level will be taken before and several times after treatment. Pictures of the tattooed area being removed will be taken before and after treatment, and at each follow-up evaluation.
Follow up evaluations will be performed at 1 week, two weeks, one month and two months post treatment. Overall health and skin condition will be evaluated, and the tattoo area will be pictured. Efficacy of tattoo removal will be evaluated after two months, by visual estimation of the percent area that reacted to treatment, and the change in brightness (both evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin condition, the study treatment will be stopped (if treatment is successful), or may be repeated (up to a limit of two additional times) if the tattoo was not completely removed.
The results of tattoo removal using both washing fluids will be analyzed and compared. A result of 3 or more on the brightness change scale will be considered as a successful treatment.
Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax and AUC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects 18 years or older, of any race
- Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden)
- Subjects willing to participate as evidenced by signing the written informed consent
Key exclusion criteria (10 listed)
- Subject has a dermatological disease, active or latent (e.g. psoriasis)
- Subject has a known tendency for Keloid formation.
- Subject has a known tendency for skin hyperpigmentation.
- Subject is susceptible to Koebner reaction.
- Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
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 |
|---|---|---|
| Eraser TM device, with washing fluid | Device | – |
Primary outcome
Pigment clearance, as evaluated by image comparison on a 1-5 analog scale
Rate of systemic and dermatologic adverse events
Pharmacokinetic data for washing fluid (Cmax and AUC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2006.
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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.
Shay Efrati, MD principal investigator
Assaf Harofe Medical 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 Eraser TM device, with washing fluid in people with Tattoo and Healthy, run by Assaf-Harofeh Medical Center 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Dec 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Nesher (00-1-972-54-6511141, ori@hawkmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigment clearance, as evaluated by image comparison on a 1-5 analog scale. The study lists 3 primary outcomes in all. 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 8 Dec 2006.