Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2008
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
September 1, 2014
CompletedMarch 22, 2018
February 1, 2018
6.5 years
March 12, 2008
August 20, 2014
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream
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.
approximately 14 weeks
Study Arms (2)
1
ACTIVE COMPARATORThe tattoo will be treated with laser and imiquimod 5% cream
2
PLACEBO COMPARATORThe tattoo will be treated with laser and placebo topical cream
Interventions
The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy
2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
Eligibility Criteria
You may qualify if:
- tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/black ink.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Graceway Pharmaceuticals, LLCcollaborator
Study Sites (1)
Mohs, Dermatologic and Laser Surgery
Miami, Florida, 33136, United States
Related Publications (1)
Elsaie ML, Nouri K, Vejjabhinanta V, Rivas MP, Villafradez-Diaz LM, Martins A, Rosso R. Topical imiquimod in conjunction with Nd:YAG laser for tattoo removal. Lasers Med Sci. 2009 Nov;24(6):871-5. doi: 10.1007/s10103-009-0709-9. Epub 2009 Jul 15.
PMID: 19597914RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Keyvan Nouri
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Keyvan Nouri, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 22, 2018
Results First Posted
September 1, 2014
Record last verified: 2018-02