Background: Laser-assisted tattoo removal is effective but can be costly and time-consuming and can result in disfiguring scars and pigment alterations. Imiquimod, an immune response modifier, may play a role in tattoo removal.
Objective: The objective was to evaluate the safety and efficacy of topical 5% imiquimod cream used daily in conjunction with laser therapy to remove unwanted tattoos.
Materials and methods: Twenty subjects with two similar tattoos were enrolled in this randomized, prospective, double-blinded, case-controlled study. Tattoos were treated with either imiquimod or placebo daily and laser therapy every 4 to 6 weeks for a total of six sessions. The primary efficacy parameter was tattoo clearance (5-point scale, poor through complete). Secondary efficacy parameters included textural changes (5-point scale, minimal through severe), pain during and between laser procedures, and undesirable pigment alterations.
Results: Nineteen subjects completed the study. The mean score for tattoo clearance with imiquimod versus placebo was 3.2 versus 2.9 and, for textural changes, was 1.37 versus 1.21 (differences not statistically significant). There was no difference in subjective pain during and between laser sessions and no undesirable pigment alterations were reported. Adverse reactions were more frequent with imiquimod compared to placebo.
Conclusion: Topical imiquimod is an ineffective adjunct to laser-assisted tattoo removal.