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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00638651
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : September 1, 2014
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 19, 2008
Results First Submitted Date August 20, 2014
Results First Posted Date September 1, 2014
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Bleaching of tattoo [ Time Frame: approximately 14 weeks ]
Change History Complete list of historical versions of study NCT00638651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Bleaching of the Tattoo [ Time Frame: 14 weeks ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Official Title  ICMJE Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
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 Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2008)
12
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00638651
Other Study ID Numbers  ICMJE 20071234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Keyvan Nouri, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Graceway Pharmaceuticals, LLC
Investigators  ICMJE
Principal Investigator: Keyvan Nouri, MD University of Miami
PRS Account University of Miami
Verification Date February 2018

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