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 the 755nm Alexandrite laser.
Interventions
DEVICE755nm Alexandrite Laser
755nm Alexandrite Laser
DEVICE755nm Alexandrite Laser with CAP Array
755nm Alexandrite Laser with CAP Array
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 Using Photographic Evaluation | up to 3 months post last treatment | 2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser
755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array | 20 |
| Total | 20 |
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 | 20 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score I | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score II | 9 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score III | 6 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score IV | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score V | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Tattoo Clearance Using Photographic Evaluation
2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.
Time frame: up to 3 months post last treatment
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 755nm Alexandrite Laser | Tattoo Clearance Using Photographic Evaluation | >75% clearance | 15 Tattoos |
| 755nm Alexandrite Laser | Tattoo Clearance Using Photographic Evaluation | 51-74% clearance | 6 Tattoos |
| 755nm Alexandrite Laser | Tattoo Clearance Using Photographic Evaluation | <25% clearance | 2 Tattoos |