Trial Outcomes & Findings for Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal (NCT NCT02912507)
NCT ID: NCT02912507
Last Updated: 2023-10-04
Results Overview
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
6 weeks post-final treatment, an average of 8 months from baseline
Results posted on
2023-10-04
Participant Flow
Unit of analysis: Halves or single tattoos treated
Participant milestones
| Measure |
Single Arm Treatment - Cutera Enlighten Laser
Full tattoo will be treated with the Cutera enlighten laser
|
Split Tattoo Treatment - Cutera Enligthen Laser
Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser.
The investigational treatment will be assigned to either part A (right/top side) or part B (left/lower side) of the tattoo (based on patient's left and right).
|
Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser
Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5 5
|
5 5
|
5 5
|
|
Overall Study
COMPLETED
|
1 1
|
1 1
|
1 1
|
|
Overall Study
NOT COMPLETED
|
4 4
|
4 4
|
4 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal
Baseline characteristics by cohort
| Measure |
Single Arm Treatment
n=5 Participants
Full tattoo will be treated with the Cutera enlighten laser
|
Split Tattoo Treatment
n=5 Participants
Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-final treatment, an average of 8 months from baselineDegree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
Outcome measures
| Measure |
Single Arm Treatment
n=1 Participants
Full tattoo will be treated with the Cutera enlighten laser
|
Split Tattoo Treatment- Enlighten
n=1 Participants
Tattoo will be split and treated with the Cutera enlighten laser
|
Split Tattoo Treatment- PicoSure
n=1 Participants
Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser
|
|---|---|---|---|
|
Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
Adverse Events
Single Arm Treatment - Cutera Enlighten Laser
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Split Tattoo Treatment - Cutera Enlighten Laser
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm Treatment - Cutera Enlighten Laser
n=5 participants at risk
Full tattoo will be treated with the Cutera enlighten laser
|
Split Tattoo Treatment - Cutera Enlighten Laser
n=5 participants at risk
Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser.
The investigational treatment will be assigned to either part A (right/top side) or part B (left/lower side) of the tattoo (based on patient's left and right).
|
Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser
n=5 participants at risk
Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
5/5 • 6 weeks post final treatment, up to 8 months
|
100.0%
5/5 • 6 weeks post final treatment, up to 8 months
|
100.0%
5/5 • 6 weeks post final treatment, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Edema
|
80.0%
4/5 • 6 weeks post final treatment, up to 8 months
|
100.0%
5/5 • 6 weeks post final treatment, up to 8 months
|
100.0%
5/5 • 6 weeks post final treatment, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
40.0%
2/5 • 6 weeks post final treatment, up to 8 months
|
40.0%
2/5 • 6 weeks post final treatment, up to 8 months
|
40.0%
2/5 • 6 weeks post final treatment, up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place