Unwanted Tattoos
Conditions
Brief summary
The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the treatment of unwanted tattoos.
Interventions
DEVICEPicosure Laser System
Picosure Laser System for the Treatment of Unwanted Tattoos
DEVICERevlite Laser System
Revlite Laser System for the Treatment of Unwanted 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 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.
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 sensitizing 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 keloid scar formation. 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.14. The subject has red tattoo ink allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo Clearance | 2 months post each patient's last treatment, approximately 15 months | Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is \>75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance. |
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 | 58 |
| Revlite Laser System Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos | 5 |
| Total | 63 |
Baseline characteristics
| Characteristic | Picosure Laser System | Revlite Laser System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 5 Participants | 63 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type I | 2 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type II | 17 Participants | 1 Participants | 18 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type III | 31 Participants | 4 Participants | 35 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type IV | 5 Participants | 0 Participants | 5 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type V | 2 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type VI | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 51 Participants | 5 Participants | 56 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 5 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Female | 31 Participants | 3 Participants | 34 Participants |
| Sex: Female, Male Male | 27 Participants | 2 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 5 |
| other Total, other adverse events | 45 / 58 | 5 / 5 |
| serious Total, serious adverse events | 0 / 58 | 0 / 5 |
Outcome results
Primary
Tattoo Clearance
Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is \>75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance.
Time frame: 2 months post each patient's last treatment, approximately 15 months
Population: 11 Picosure subjects were lost to follow up, 2 subjects withdrew, and 7 subjects were not required to attend the follow up because the study was ended.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Picosure Laser System | Tattoo Clearance | 2.5 score on a scale | Standard Deviation 0.7 |
| Revlite Laser System | Tattoo Clearance | 3.0 score on a scale | Standard Deviation 0 |