Unwanted, Non Cosmetic, Tattoos
Conditions
Brief summary
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
Interventions
DEVICE755 nm alexandrite laser
755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Is a healthy male or female between 18 and 85 years old. 2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them. 3. Is willing to consent to participate in the study. 4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
Exclusion criteria
1. Is hypersensitive to light exposure. 2. Has active localized or systemic infection. 3. Is taking medication(s) for which sunlight is a contraindication. 4. Has a history of squamous cell carcinoma or melanoma. 5. Has a history of keloid scarring. 6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. 7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. 8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine. 10. Has any other reason determined by the physician to be ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo Clearance | Post Treatment 1 (6 Weeks Post Baseline) | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. |
Countries
United States
Participant flow
Pre-assignment details
All subjects are enrolled in both study arms because all subjects will be receiving treatment on the left side of the tattoo and treatment on the right side of the tattoo in each visit.
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | 755nm Alexandrite Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type I | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type II | 6 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type III | 7 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type IV | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type V | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Time frame: Post Treatment 1 (6 Weeks Post Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Tattoo Clearance | 2.875 score on a scale | Standard Deviation 2.112 |
| 755nm Alexandrite Laser Double Pass (Left Side) | Tattoo Clearance | 4.25 score on a scale | Standard Deviation 2.513 |
Comparison: This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).p-value: 0.0077t-test, 2 sided
Primary
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Time frame: Post Treatment 2 (12 Weeks Post Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Tattoo Clearance | 3.75 score on a scale | Standard Deviation 2.21 |
| 755nm Alexandrite Laser Double Pass (Left Side) | Tattoo Clearance | 4.88 score on a scale | Standard Deviation 2.58 |
Comparison: This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).p-value: 0.00012t-test, 2 sided
Primary
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Time frame: Post Treatment 3 (18 Weeks Post Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Tattoo Clearance | 4.5 score on a scale | Standard Deviation 2.48 |
| 755nm Alexandrite Laser Double Pass (Left Side) | Tattoo Clearance | 5.77 score on a scale | Standard Deviation 2.83 |
Comparison: This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).p-value: 0.0034t-test, 2 sided