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

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

September 24, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638651 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream

Study Arms / Comparison Groups

Active Comparator: The tattoo will be treated with laser and imiquimod 5% cream
Placebo Comparator: The tattoo will be treated with laser and placebo topical cream

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

February 2009 (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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00638651

Responsible Party

Keyvan Nouri, MD, Department of Dermatology and Cutaneous Surgery - University of Miami

Study ID Numbers ^ICMJE

20071234

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Graceway Pharmaceuticals, LLC

Investigators ^ICMJE

Principal Investigator:

Keyvan Nouri, MD

University of Miami

Information Provided By

University of Miami

Verification Date

February 2008

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