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OpenTrials
Completed

NCT Number: NCT00638651

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mohs, Dermatologic and Laser Surgery

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1064 nm Nd:YAG laser

Device

The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy

Imiquimod, 5% cream

Drug

2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month

Other names: Aldara

Primary outcomes

  1. Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Graceway Pharmaceuticals, LLC

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2008
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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