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
Recruitment status was Recruiting
Sponsor:
University of Miami
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00638651
First received: March 12, 2008
Last updated: September 24, 2009
Last verified: February 2008
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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 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:
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
Graceway Pharmaceuticals, LLC
Investigators
| Principal Investigator: | Keyvan Nouri, MD | University of Miami |
More Information
Additional Information:
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 May 23, 2013