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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Imiquimod, 5% cream

• Registration Number: NCT00638651
• Lead Sponsor: University of Miami

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2014-08-20
• Results First Submitted QC: 2014-08-20
• Results First Posted: 2014-09-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Imiquimod, 5% cream	The tattoo will be treated with laser and imiquimod 5% cream

Primary Outcome Measures

Name	Time	Method
Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream	approximately 14 weeks	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.

Trial Locations

Locations (1)

Mohs, Dermatologic and Laser Surgery; 🇺🇸 Miami, Florida, United States