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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638651
First Posted: March 19, 2008
Last Update Posted: August 23, 2017
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.
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Keyvan Nouri, University of Miami:

Primary Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: February 2008
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638651


Locations
United States, Florida
Mohs, Dermatologic and Laser Surgery
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Graceway Pharmaceuticals, LLC
Investigators
Principal Investigator: Keyvan Nouri, MD University of Miami
  More Information

Publications:
Responsible Party: Keyvan Nouri, MD, University of Miami
ClinicalTrials.gov Identifier: NCT00638651     History of Changes
Other Study ID Numbers: 20071234
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: August 20, 2014
Results First Posted: September 1, 2014
Last Update Posted: August 23, 2017
Last Verified: July 2017

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

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