The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod 5% cream in conjunction with the 1,064-nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser treatment alone, which is the standard for cosmetic removal of tattoos. Previous studies have linked partial tattoo removal to imiquimod application in a guinea pig model. Methods: This was a small-sized, double-blinded, placebo-controlled trial with patients with Fitzpatrick skin types I-IV (light skin) who were 18-65 years of age. The patients were required to have had two tattoos of similar age and dark blue or black in color in areas that can be covered by clothing. There were four visits in total, with laser treatment and photography being performed on the first visit. Laser settings were with 1,064-nm Nd:YAG with a 10-ns pulse, 3-mm spot size, and 4 J of energy, a standard laser used for tattoo removal. During the second visit, tattoos were randomized and chosen to receive either the laser-imiquimod treatment course or laser-vehicle cream treatment. The patients returned 1 month after the completion of cream application (week #10) and 2 months after the completion of treatment with cream (week #14) for final evaluation and photographing. Results: Three patients were enrolled in this study. All of them are Fitzpatrick skin type IV. All of the patients were compliant with the drug application and have good tolerability with only mild pruritus without changing of vascularity or pigmentation. None of the patients had ulceration or scar development during the cream application. Conclusions: imiquimod plus laser therapy demonstrated a more favorable outcome when evaluated by the investigators or subjects. The mean scores for tattoo clearance from baseline to 2 months after completion of treatment with 5% imiquimod cream versus placebo cream were 4.3 versus 2.7 as rated by investigators and 4.7 versus 2.3 as rated by subjects. No textural changes were observed after therapy and were not shown to be different between the two groups. Further large-scale studies are important in developing a role for the use of imiqumod in laser-assisted tattoo removal.
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