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| Name | Class |
|---|---|
| Graceway Pharmaceuticals, LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.
Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | The tattoo will be treated with laser and imiquimod 5% cream |
|
| 2 | Placebo Comparator | The tattoo will be treated with laser and placebo topical cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1064 nm Nd:YAG laser | Device | The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream | To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone. | approximately 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keyvan Nouri, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohs, Dermatologic and Laser Surgery | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19597914 | Result | Elsaie ML, Nouri K, Vejjabhinanta V, Rivas MP, Villafradez-Diaz LM, Martins A, Rosso R. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. Lasers Med Sci. 2009 Nov;24(6):871-5. doi: 10.1007/s10103-009-0709-9. Epub 2009 Jul 15. |
| Label | URL |
|---|---|
| Principal investigator biography | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Treatment With Imiquimod Cream or Placebo | Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatment With Imiquimod Cream or Placebo | One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream. |
| 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 | Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream | To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone. | Posted | Mean | Full Range | percentage of tattoo pigment removed | approximately 14 weeks | Tattoo | Tattoo |
|
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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 | Laser Treatment With Imiquimod Cream or Placebo | One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keyvan Nouri | University of Miami | 305-243-3380 | knouri@med.miami.edu |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Imiquimod, 5% cream | Drug | 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
The tattoo will be treated with laser and placebo topical cream 1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy |
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| 0 |
| 3 |
| 0 |
| 3 |
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| D006571 | Heterocyclic Compounds |