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

First Received on March 12, 2008. Last Updated on September 24, 2009 History of Changes

Sponsor:	University of Miami
Collaborator:	Medicis Global Service Corporation
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00638651

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 I

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:

Drug Information available for: S 26308

U.S. FDA Resources

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

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

Medicis Global Service Corporation

Investigators

Principal Investigator:

Keyvan Nouri, MD

University of Miami

More Information

Additional Information:

Principal investigator biography This link exits the ClinicalTrials.gov site

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 February 12, 2012