Removal of Colors Tattoo (Multiple Colors)NCT00904631
A Prospective, Open Label, Non Randomized, Clinical Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
A study testing Eraser device+ salicylic acid (5%) in people with Removal of Colors Tattoo (Multiple Colors), run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Name of Device: Eraser Tattoo Removal Device Device Description: The Eraser device is a mechanical device, resembling tattoo devices but with an innovative mechanism for dripping treatment fluid over reciprocating needles and returning used fluid into a reservoir chamber. The device is intended for removal of tattoos. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Removal of Colors Tattoo (Multiple Colors)
- What is being tested?
- Eraser device+ salicylic acid (5%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Aug 2010
- 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 (stainless steel for needles; salicylic acid; aspirin; K-Y gel).
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- Subject has medical conditions that may be worsened by concomitant use of aspirin (Hematologic, renal, GI, hepatic or gastrointestinal contraindications; viral illness or fever; old age increases susceptibility to toxic effects); topical salicylic acid (condylomata acumynata, open wounds, burns, diabetes mellitus, peripheral vascular disease, skin and skin structure infections, skin inflammation, skin irritation) or worsened by local anesthesia materials.
- Subject is taking aspirin or anti-coagulant medications; or using topical salicylic acid preparations.
- Female subject who is pregnant or lactating.
- Subject participates in any other clinical study at the same time
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Tsrifin, 70300
Shai Efrati, MD, +972-577-346364, efratishai@013.net
Shai Efrati, MD
About this study
Name of Device: Eraser Tattoo Removal Device
Device Description: The Eraser device is a mechanical device, resembling tattoo devices but with an innovative mechanism for dripping treatment fluid over reciprocating needles and returning used fluid into a reservoir chamber. The device is intended for removal of tattoos.
Read more
Objectives: This study is a continuation of a previous feasibility study, which tested the ability of the device to remove tattoos from small skin areas. The purpose of this study is to evaluate the safety and effectiveness of the Eraser Tattoo Removal system for removal of skin tattoos in their entirety.
Subject Population: 20 patients in the medical center. Subject enrollment will include (i) a variety of tattoo colors (multiple colors) (ii) a variety of tattoo composition, contour lines and shadings (iii) Subjects with different skin colors (white, tanned, dark, etc…) (iv) professional and amateur tattoos.
Structure: A prospective, non-randomized, open, clinical study designed according to FDA guidelines; ISO 14155: standard for clinical studies of medical devices; and the procedures of the Israeli Ministry of Health for clinical studies.
After informed consent is signed, demographic details and medical history will be taken and a physical examination performed. Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). All subjects must refrain from exposure to the sun for 90 days following each treatment.
Follow-up: The subject will return for follow-up at one week, two weeks, 1 month and two months (if tattoo removal and skin healing is complete), or up to six months (if skin healing/ tattoo removal are not complete by two months), or until the healing of the tattoo removal site is completely resolved or until the investigator determines that additional treatments will provide no further benefit to the patient. In each follow-up visit, a physician will perform a physical examination, check the skin over and around the treatment area, and take photographs of the treated area. Images from last follow-up will be compared with images of the same site taken before the removal procedure, for evaluation of treatment efficacy and safety.
Repeat treatments: if tattoo removal is not complete, up to two additional treatments will be performed, based on the investigator's discretion. After each treatment, follow-up will continue as described above.
Blinding: Non-Applicable Concurrent Control: There is no concurrent control group in this study. Images of tattoos before treatment will serve as the reference measure, to which images of healed skin, several weeks after tattoo removal, will be compared.
Sample Size: 20 subjects will be enrolled in the study. Primary Effectiveness Variables: The primary measure of effectiveness will be the pigment clearance, as evaluated by image comparison on a 1-5 analog scale (5 - 81-100% clearance- excellent removal; 4 - 61-80% - good removal; 3 - 41-60% - moderate removal; 2 - 21-40% - fair removal; 1 - 0-20% - poor removal). Effectiveness will be calculated for the total study group and for individual sub-groups (skin type, pigment colors, etc.). Effectiveness will be analyzed separately for the area affected (percentage of treated area that showed any reaction to treatment) and for the change in color brightness (if, due to technical reasons, part of the tattoo showed a major effect, this area will be evaluated for the change in color brightness). For both analyses, the same scale will be used.
For safety assessment, the rate of systemic and dermatologic adverse events will be calculated and reported. The data will be listed by type of event and by severity. Specifically, textural change, hypo- and hyper- pigmentation will be followed and their rates calculated.
Data Analysis: For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale.
Study Sponsor: Hawk Medical Technologies Ltd.
- Being tested
- Eraser device+ salicylic acid (5%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eraser device+ salicylic acid (5%)Device
Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). Receives: Device: Eraser device+ salicylic acid (5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Removal of Colors Tattoo (Multiple Colors)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904631
- Sponsor's protocol ID
- 33/08
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 20 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Non Randomized, Clinical Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
- ClinicalTrials.gov ID
- NCT00904631
- Acronym / sponsor ID
- 33/08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 20 May 2009 (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.
Name of Device: Eraser Tattoo Removal Device
Device Description: The Eraser device is a mechanical device, resembling tattoo devices but with an innovative mechanism for dripping treatment fluid over reciprocating needles and returning used fluid into a reservoir chamber. The device is intended for removal of tattoos.
Objectives: This study is a continuation of a previous feasibility study, which tested the ability of the device to remove tattoos from small skin areas. The purpose of this study is to evaluate the safety and effectiveness of the Eraser Tattoo Removal system for removal of skin tattoos in their entirety.
Subject Population: 20 patients in the medical center. Subject enrollment will include (i) a variety of tattoo colors (multiple colors) (ii) a variety of tattoo composition, contour lines and shadings (iii) Subjects with different skin colors (white, tanned, dark, etc…) (iv) professional and amateur tattoos.
Structure: A prospective, non-randomized, open, clinical study designed according to FDA guidelines; ISO 14155: standard for clinical studies of medical devices; and the procedures of the Israeli Ministry of Health for clinical studies.
After informed consent is signed, demographic details and medical history will be taken and a physical examination performed. Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). All subjects must refrain from exposure to the sun for 90 days following each treatment.
Follow-up: The subject will return for follow-up at one week, two weeks, 1 month and two months (if tattoo removal and skin healing is complete), or up to six months (if skin healing/ tattoo removal are not complete by two months), or until the healing of the tattoo removal site is completely resolved or until the investigator determines that additional treatments will provide no further benefit to the patient. In each follow-up visit, a physician will perform a physical examination, check the skin over and around the treatment area, and take photographs of the treated area. Images from last follow-up will be compared with images of the same site taken before the removal procedure, for evaluation of treatment efficacy and safety.
Repeat treatments: if tattoo removal is not complete, up to two additional treatments will be performed, based on the investigator's discretion. After each treatment, follow-up will continue as described above.
Blinding: Non-Applicable Concurrent Control: There is no concurrent control group in this study. Images of tattoos before treatment will serve as the reference measure, to which images of healed skin, several weeks after tattoo removal, will be compared.
Sample Size: 20 subjects will be enrolled in the study. Primary Effectiveness Variables: The primary measure of effectiveness will be the pigment clearance, as evaluated by image comparison on a 1-5 analog scale (5 - 81-100% clearance- excellent removal; 4 - 61-80% - good removal; 3 - 41-60% - moderate removal; 2 - 21-40% - fair removal; 1 - 0-20% - poor removal). Effectiveness will be calculated for the total study group and for individual sub-groups (skin type, pigment colors, etc.). Effectiveness will be analyzed separately for the area affected (percentage of treated area that showed any reaction to treatment) and for the change in color brightness (if, due to technical reasons, part of the tattoo showed a major effect, this area will be evaluated for the change in color brightness). For both analyses, the same scale will be used.
For safety assessment, the rate of systemic and dermatologic adverse events will be calculated and reported. The data will be listed by type of event and by severity. Specifically, textural change, hypo- and hyper- pigmentation will be followed and their rates calculated.
Data Analysis: For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale.
Study Sponsor: Hawk Medical Technologies Ltd.
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: Eraser device+ salicylic acid (5%)Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). |
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 device+ salicylic acid (5%)Subjects will be treated with the Eraser device, using salicylic acid (5%) as washing fluid. The skin will be examined by a physician and the tattoo area will be photographed. The Eraser device will be used to remove the tattoo from the entire tattoo area (up to 30 minutes in a single session). An absorbent bandage will be put on the treated area for one-hour post treatment. After Care Treatment, based on a Dermatologist's consultation, will be performed on a case-by-case basis (for example, use of antibiotic ointments in case of infection). | Device | Treatment |
Primary outcome
For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale.
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
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.
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 device+ salicylic acid (5%) in people with Removal of Colors Tattoo (Multiple Colors), 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 20 May 2009. 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 Shai Efrati, MD (+972-577-346364, efratishai@013.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For this clinical study, descriptive statistics will be used. Successful treatment will be a result of 3 or more (at least, moderate tattoo removal) on the brightness change scale. (time frame: two months). 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 20 May 2009.