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

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier:
NCT00638651
First received: March 12, 2008
Last updated: August 20, 2014
Last verified: August 2014

March 12, 2008
August 20, 2014
February 2008
August 2014   (final data collection date for primary outcome measure)
Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream [ Time Frame: approximately 14 weeks ] [ Designated as safety issue: Yes ]
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.
Bleaching of tattoo [ Time Frame: approximately 14 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00638651 on ClinicalTrials.gov Archive Site
Bleaching of the Tattoo [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
    Other Name: Aldara
  • Active Comparator: 1
    The tattoo will be treated with laser and imiquimod 5% cream
    Interventions:
    • Device: 1064 nm Nd:YAG laser
    • Drug: Imiquimod, 5% cream
  • Placebo Comparator: 2
    The tattoo will be treated with laser and placebo topical cream
    Intervention: Device: 1064 nm Nd:YAG laser
Elsaie ML, Nouri K, Vejjabhinanta V, Rivas MP, Villafradez-Diaz LM, Martins A, Rosso R. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. Lasers Med Sci. 2009 Nov;24(6):871-5. doi: 10.1007/s10103-009-0709-9. Epub 2009 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00638651
20071234
Yes
Keyvan Nouri, University of Miami
University of Miami
Graceway Pharmaceuticals, LLC
Principal Investigator: Keyvan Nouri, MD University of Miami
University of Miami
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP