Trial Outcomes & Findings for Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos (NCT NCT02110121)
NCT ID: NCT02110121
Last Updated: 2021-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
2 months post each patient's last treatment, approximately 15 months
Results posted on
2021-02-09
Participant Flow
Participant milestones
| Measure |
Picosure Laser System
Picosure Laser System for the Treatment of Unwanted Tattoos
Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
|
Revlite Laser System
Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
5
|
|
Overall Study
COMPLETED
|
42
|
5
|
|
Overall Study
NOT COMPLETED
|
16
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos
Baseline characteristics by cohort
| Measure |
Picosure Laser System
n=58 Participants
Picosure Laser System for the Treatment of Unwanted Tattoos
Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
|
Revlite Laser System
n=5 Participants
Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
51 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type I
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type II
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type III
|
31 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type IV
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type V
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type VI
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 months post each patient's last treatment, approximately 15 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Picosure Laser System
n=81 tattoos
Picosure Laser System for the Treatment of Unwanted Tattoos
Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
|
Revlite Laser System
n=5 tattoos
Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos
|
|---|---|---|
|
Tattoo Clearance
|
2.5 score on a scale
Standard Deviation .7
|
3.0 score on a scale
Standard Deviation 0.0
|
Adverse Events
Picosure Laser System
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Revlite Laser System
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 |
Picosure Laser System
n=58 participants at risk
Picosure Laser System for the Treatment of Unwanted Tattoos
Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos
|
Revlite Laser System
n=5 participants at risk
Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Pinpoint Bleeding
|
44.8%
26/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
100.0%
5/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.4%
2/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Blistering
|
17.2%
10/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
20.0%
1/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Redness
|
39.7%
23/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
80.0%
4/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
29.3%
17/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
60.0%
3/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.7%
1/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Other
|
3.4%
2/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
40.0%
2/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Scabs
|
5.2%
3/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.2%
3/58 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
0.00%
0/5 • Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER