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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00638651
First received: March 12, 2008
Last updated: September 24, 2009
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Bleaching of tattoo [ Time Frame: approximately 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bleaching of the tattoo [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: February 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The tattoo will be treated with laser and imiquimod 5% cream
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
Placebo Comparator: 2
The tattoo will be treated with laser and placebo topical cream
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638651

Contacts
Contact: Angela Martins, MD 305-243-4184 amartins@med.miami.edu
Contact: Voraphol Vejjabhinanta, MD 305-243-4184 vvejjabhinanta@med.miami.edu

Locations
United States, Florida
Mohs, Dermatologic and Laser Surgery Recruiting
Miami, Florida, United States, 33136
Contact: Angela Martins, MD    305-243-4184    amartins@med.miami.edu   
Contact: Voraphol Vejjabhinanta, MD    305-243-4184    vvejjabhinanta@med.miami.edu   
Principal Investigator: Keyvan Nouri, MD         
Sponsors and Collaborators
University of Miami
Graceway Pharmaceuticals, LLC
Investigators
Principal Investigator: Keyvan Nouri, MD University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Keyvan Nouri, MD, Department of Dermatology and Cutaneous Surgery - University of Miami
ClinicalTrials.gov Identifier: NCT00638651     History of Changes
Other Study ID Numbers: 20071234
Study First Received: March 12, 2008
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Tattoos
Black/blue tattoos

Additional relevant MeSH terms:
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on August 26, 2014