Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

Conditions
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Healthy

Intervention / Treatment
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* Device: 1064 nm Nd:YAG laser
* Drug: Imiquimod, 5% cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink. Exclusion Criteria: Hypersensitivity to imiquimod Current sun tan Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days Amateur tattoos Pregnancy Breast-feeding status Immunosuppression Auto-immune diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The tattoo will be treated with laser and imiquimod 5% cream | Device: 1064 nm Nd:YAG laser<br>* The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy<br>Drug: Imiquimod, 5% cream<br>* 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month<br>* Other names: Aldara;|
| Placebo Comparator: 2<br>The tattoo will be treated with laser and placebo topical cream | Device: 1064 nm Nd:YAG laser<br>* The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tattoos, Black/blue tattoos