Trial Outcomes & Findings for Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal (NCT NCT01973166)
NCT ID: NCT01973166
Last Updated: 2023-02-21
Results Overview
Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent 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%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
6-weeks post-final treatment
Results posted on
2023-02-21
Participant Flow
Unit of analysis: halves of tattoo
Participant milestones
| Measure |
All Study Participants
Subject tattoos were divided into 2 portions for assignment into 2 treatment arms: active control arm and treatment arm. One tattoo portion was treated with the Cutera Investigational picosecond Q-Switched Nd:YAG laser and the other tattoo portion with a comparator nanosecond Q-switched Nd:YAG laser
|
|---|---|
|
Overall Study
STARTED
|
42 84
|
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Overall Study
Treatment With Cutera Investigational Picosecond Q-Switched Nd:YAG Laser
|
42 42
|
|
Overall Study
Treatment With Comparator Nanosecond Q-switched Nd:YAG Laser
|
42 42
|
|
Overall Study
COMPLETED
|
41 82
|
|
Overall Study
NOT COMPLETED
|
1 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal
Baseline characteristics by cohort
| Measure |
Picosecond and Nanosecond Q-Switched Laser Treatment
n=42 Participants
Picosecond and Nanosecond Q-Switched Laser Treatment (532 nm and 1064 nm)
|
|---|---|
|
Age, Continuous
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34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeks post-final treatmentPhysician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent 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 Treatment
n=41 Participants
Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Picosecond Q-switched Laser Treatment
|
Nanosecond Q-switched Laser Treatment
n=41 Participants
Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Nanosecond Q-switched Laser Treatment
|
|---|---|---|
|
Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers.
|
2.54 score on a scale
Interval 2.13 to 2.94
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2.17 score on a scale
Interval 1.77 to 2.57
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SECONDARY outcome
Timeframe: During treatment, approximately 10 minutesNumeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome
Outcome measures
| Measure |
Picosecond Q-switched Laser Treatment
n=42 Participants
Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Picosecond Q-switched Laser Treatment
|
Nanosecond Q-switched Laser Treatment
n=42 Participants
Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser
Nanosecond Q-switched Laser Treatment
|
|---|---|---|
|
Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment
|
4.1 score on a scale
Interval 0.5 to 9.0
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4.4 score on a scale
Interval 0.0 to 9.0
|
Adverse Events
Picosecond Q-Switched Laser Treatment
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Nanosecond Q-Switched Laser Treatment
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Picosecond Q-Switched Laser Treatment
n=42 participants at risk
Picosecond Q-Switched Laser Treatment (532 nm and 1064 nm)
|
Nanosecond Q-Switched Laser Treatment
n=42 participants at risk
Nanosecond Q-Switched Laser Treatment (532 nm and 1064 nm)
|
|---|---|---|
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Skin and subcutaneous tissue disorders
Pinpoint Bleeding
|
76.2%
32/42
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47.6%
20/42
|
|
Skin and subcutaneous tissue disorders
Edema
|
100.0%
42/42
|
100.0%
42/42
|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
42/42
|
100.0%
42/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place