Tattooing
Conditions
Keywords
Tattoo removal, ultrasound
Brief summary
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.
Interventions
DEVICECupola Tattoo Removal device
Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
Sponsors
Cupola Medical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo Removal Efficiency | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Score | 0, 2, 4, 6, 8, 10 weeks (after every treatment) | 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. |
Countries
Israel
Participant flow
Recruitment details
Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic
Participants by arm
| Arm | Count |
|---|---|
| Treatment Cupola tattoo removal treatment | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 32.1 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Israel | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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: 1. Scoring by independent dermatologist 2. Measuring pigment clearance using image analysis
Time frame: 6 months (termination)
Population: The number of participants that completed follow up.
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.
Time frame: 0, 2, 4, 6, 8, 10 weeks (after every treatment)