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| Sponsors and Collaborators: |
University of Miami Graceway Pharmaceuticals, LLC |
|---|---|
| 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: | 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 |
| 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
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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
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Angela Martins, MD | 305-243-4184 | amartins@med.miami.edu |
| Contact: Voraphol Vejjabhinanta, MD | 305-243-4184 | vvejjabhinanta@med.miami.edu |
| 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 | |
| Principal Investigator: | Keyvan Nouri, MD | University of Miami |
More Information
| Responsible Party: | Department of Dermatology and Cutaneous Surgery - University of Miami ( Keyvan Nouri, MD ) |
| Study ID Numbers: | 20071234 |
| Study First Received: | March 12, 2008 |
| Last Updated: | March 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00638651 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tattoos Black/blue tattoos |
|
Immunologic Factors Interferons Adjuvants, Immunologic Imiquimod Healthy |
|
Interferon Inducers Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Imiquimod Pharmacologic Actions |
