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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Device: 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
• Drug: Imiquimod, 5% cream
  • 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • The tattoo will be treated with laser and imiquimod 5% cream
• Placebo Comparator: 2
  • The tattoo will be treated with laser and placebo topical cream

Primary Measures

• Bleaching of tattoo
  • Time Frame: approximately 14 weeks
    Safety Issue?: Yes

Secondary Measures

• Bleaching of the tattoo
  • Time Frame: 14 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Miami

Overall Clinical Trial Officials and Contacts

Keyvan Nouri, MD Principal Investigator University of Miami  

Overall Contact: Angela Martins, MD 305-243-4184 amartins@med.miami.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638651

Study ID Number: 20071234

ClinicalTrials.gov Identifier: NCT00638651

Health Authority: United States: Food and Drug Administration

Principal investigator biography