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

University of Miami logo

University of Miami

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Imiquimod, 5% cream
Device: 1064 nm Nd:YAG laser

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00638651
20071234

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

3 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
The tattoo will be treated with laser and imiquimod 5% cream
Treatment:
Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream
2
Placebo Comparator group
Description:
The tattoo will be treated with laser and placebo topical cream
Treatment:
Device: 1064 nm Nd:YAG laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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