Unwanted Tattoos
Conditions
Brief summary
The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.
Interventions
DEVICEPicosure Laser System
Picosure Laser System for the Treatment of Unwanted Tattoos
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. Is willing to consent to participate in the study. 3. 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. 4. The tattoo must include red pigment.
Exclusion criteria
1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. Is hypersensitive to light exposure OR takes photo sensitized medication. 3. Has active or localized systemic infections. 4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}). 5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. 7. Has used Accutane within 6 months prior to enrollment. 8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. Has a history of keloids. 11. Has evidence of compromised wound healing. 12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. 13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder. 14. Is allergic to topical lidocaine or topical steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Tattoo Clearance | 2 months post last treatment | Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Satisfaction Questionnaire | 2 months post last treatment | This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Picosure Laser System Picosure Laser System for the treatment of unwanted tattoos
Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Picosure Laser System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type I | 2 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type II | 5 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type III | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type IV | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type V | 3 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type VI | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Indian | 0 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Patients With Tattoo Clearance
Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.
Time frame: 2 months post last treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Picosure Laser System | Number of Patients With Tattoo Clearance | # of Patients with 20% Improvement | 3 Participants |
| Picosure Laser System | Number of Patients With Tattoo Clearance | # of Patients with 30% Improvement | 5 Participants |
Secondary
Physician Satisfaction Questionnaire
This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.
Time frame: 2 months post last treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Picosure Laser System | Physician Satisfaction Questionnaire | Patients scored a 5 by physician | 4 Participants |
| Picosure Laser System | Physician Satisfaction Questionnaire | Patients scored a 4 by Physician | 4 Participants |