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Sponsor decided that the results were not significant enough to continue.
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The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Cupola Tattoo Removal Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cupola Tattoo Removal device | Device | Up to 6 treatments with the device every 2-3 weeks to the tattoo area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 6 months (termination) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 2, 4, 6, 8, 10 weeks (after every treatment) |
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Inclusion Criteria:
Tattoos
General
Exclusion Criteria:
Skin conditions
Other medical conditions
Medication
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| Name | Affiliation | Role |
|---|---|---|
| David J Friedman, M.D. | Friedman Skin & Laser Center | Principal Investigator |
| Lilach Gavish, Ph.D. | Friedman Skin & Laser Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr David Friedman Laser & Skin Center, Diskin 60 st. | Jerusalem | Israel |
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Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Cupola tattoo removal treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Cupola tattoo removal treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| The number of participants that completed follow up. | Posted | 6 months (termination) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Cupola tattoo removal treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild thickening of the skin | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Friedman, Principal Investigator | Dr David Friedman Laser & Skin Center | +972-2-5635673 | drfriedmanlaser@gmail.com |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Not Posted | 0, 2, 4, 6, 8, 10 weeks (after every treatment) |
| 0 |
| 8 |
| 2 |
| 8 |
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