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
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 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. Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment
Exclusion criteria
1. The subject 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. The subject is hypersensitive to light exposure OR takes photo sensitized medication. 3. The subject has active or localized systemic infections. 4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. The subject 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. The subject has used Accutane within 6 months prior to enrollment. 8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. The subject has a history of keloids. 11. The subject has evidence of compromised wound healing. 12. The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. 13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo Clearance Percentage Using a Photographic Scale | 1-3 month follow up post each subject's last treatment, an average of 17.5 months | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction | Baseline and 2 months post last treatment follow up (+/- 1 month) | Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from extremely satisfied (3) to extremely dissatisfied (0). |
| Subject Satisfaction | Baseline and 2 months post last treatment follow up (+/- 1 month) | Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from extremely satisfied (3) to extremely dissatisfied (0). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Picosure Laser System Picosure Laser System | 44 |
| Total | 44 |
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 | 44 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score I | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score II | 13 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score III | 18 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score IV | 8 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score V | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score VI | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 27 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiple | 6 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 41 |
| other Total, other adverse events | 27 / 27 | 27 / 27 | 41 / 41 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 41 |
Outcome results
Primary
Tattoo Clearance Percentage Using a Photographic Scale
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo.
Time frame: 1-3 month follow up post each subject's last treatment, an average of 17.5 months
Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Picosure Laser System | Tattoo Clearance Percentage Using a Photographic Scale | 84.7 percentage of clearance | Standard Deviation 16.9 |
Secondary
Investigator Satisfaction
Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from extremely satisfied (3) to extremely dissatisfied (0).
Time frame: Baseline and 2 months post last treatment follow up (+/- 1 month)
Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Picosure Laser System | Investigator Satisfaction | Number of Tattoo Results Investigator Was Extremely Dissatisfied With | 0 tattoos |
| Picosure Laser System | Investigator Satisfaction | Number of Tattoo Results Investigator Was Dissatisfied With | 1 tattoos |
| Picosure Laser System | Investigator Satisfaction | Number of Tattoo Results Investigator Was Satisfied With | 19 tattoos |
| Picosure Laser System | Investigator Satisfaction | Number of Tattoo Results Investigator Was Extremely Satisfied With | 14 tattoos |
Secondary
Subject Satisfaction
Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from extremely satisfied (3) to extremely dissatisfied (0).
Time frame: Baseline and 2 months post last treatment follow up (+/- 1 month)
Population: 12 subjects were lost to follow up, and 5 subjects withdrew consent.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Picosure Laser System | Subject Satisfaction | Number of Tattoo Subjects Were Extremely Dissatisfied With | 1 tattoos |
| Picosure Laser System | Subject Satisfaction | Number of Tattoo Subjects Were Satisfied With | 17 tattoos |
| Picosure Laser System | Subject Satisfaction | Number of Tattoo Subjects Were Extremely Satisfied With | 11 tattoos |
| Picosure Laser System | Subject Satisfaction | Number of Tattoo Subjects Were Dissatisfied With | 5 tattoos |