Trial Outcomes & Findings for A Clinical Evaluation for Tattoo Removal (NCT NCT02756806)
NCT ID: NCT02756806
Last Updated: 2023-02-21
Results Overview
Degree of tattoo clearing at 12 weeks post-final treatment as assessed by independent blinded reviewers (Physician's Global Assessment of Improvement). Min=0; Max=4 Higher score indicate better tattoo clearing 4= Very Significant Clearing (\>75%) 3 = Significant Clearing (51-75%) 2 = Moderate Clearing (26-50%) 1 = Mild Clearing (5-25%) 0 = No Change (\<5%)
TERMINATED
NA
7 participants
12-weeks post-final treatment
2023-02-21
Participant Flow
Participant milestones
| Measure |
Picosecond Q-switched Laser
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Picosecond Q-switched Laser
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
|
|---|---|
|
Overall Study
Study terminated early
|
5
|
Baseline Characteristics
A Clinical Evaluation for Tattoo Removal
Baseline characteristics by cohort
| Measure |
Picosecond Q-switched Laser
n=7 Participants
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
Picosecond Q-switched laser: Each subject will receive up to 6 laser treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
45 YEARS
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12-weeks post-final treatmentDegree of tattoo clearing at 12 weeks post-final treatment as assessed by independent blinded reviewers (Physician's Global Assessment of Improvement). Min=0; Max=4 Higher score indicate better tattoo clearing 4= Very Significant Clearing (\>75%) 3 = Significant Clearing (51-75%) 2 = Moderate Clearing (26-50%) 1 = Mild Clearing (5-25%) 0 = No Change (\<5%)
Outcome measures
| Measure |
Picosecond Q-switched Laser
n=2 Participants
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
Picosecond Q-switched laser: Each subject will receive up to 6 laser treatments.
|
|---|---|
|
Degree of Tattoo Clearing
|
3 score on a scale
Standard Deviation 0
|
Adverse Events
Picosecond Q-switched Laser
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Picosecond Q-switched Laser
n=7 participants at risk
Treatment with investigational wavelengths of the Cutera enlighten laser for tattoo removal.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Frosting
|
100.0%
7/7
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
7/7
|
|
Skin and subcutaneous tissue disorders
Edema
|
100.0%
7/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place