Healthy
Conditions
Keywords
Tattoos, Black/blue tattoos
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.
Interventions
DEVICE1064 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
DRUGImiquimod, 5% cream
2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
Sponsors
Graceway Pharmaceuticals, LLC
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream | approximately 14 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment With Imiquimod Cream or Placebo One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Laser Treatment With Imiquimod Cream or Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Time frame: approximately 14 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Laser Treatment With Imiquimod (Group 1) | Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream | 4.3 percentage of tattoo pigment removed |
| Laser Treatment With Placebo Cream (Group 2) | Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream | 2.7 percentage of tattoo pigment removed |