Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal - Full Text View

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

ChemIDplus related topics:

S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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
1: Active Comparator 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
2: Placebo Comparator 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

Graceway Pharmaceuticals, LLC

Investigators


Principal Investigator:	Keyvan Nouri, MD	University of Miami

More Information

Principal investigator biography This link exits the ClinicalTrials.gov site

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

Keywords provided by University of Miami:

Tattoos

Black/blue tattoos

Study placed in the following topic categories:

Interferons

Imiquimod

Healthy

Interferon Alfa-2b

Additional relevant MeSH terms:

Interferon Inducers

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Miami Graceway Pharmaceuticals, LLC
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00638651