Trial Outcomes & Findings for Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal (NCT NCT02244554)

Results Overview

Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-02-21

Unit of analysis: Sides of tattoos treated

Participant milestones
Measure	All Study Participants Subject tattoos were divided into 2 sides for assignment into 2 arms for treatment by the Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) : active control arm and treatment arm. One side will receive treatment with the picosecond pulse duration and one side will receive treatment with the nanosecond pulse duration.
Overall Study STARTED	10 20
Overall Study Treatment With Picosecond Pulse Duration	10 10
Overall Study Treatment With Nanosecond Pulse Duration	10 10
Overall Study COMPLETED	10 20
Overall Study NOT COMPLETED	0 0

Withdrawal data not reported

Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal

Baseline characteristics by cohort
Measure	All Enrolled Subjects All Enrolled Subjects n=10 Participants Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants

Timeframe: 12 weeks

Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes

Outcome measures
Measure	enLighten Laser Picosecond Pulse n=10 Participants Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Picosecond pulse-duration pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment	enLighten Laser Nanosecond Pulse n=10 Participants Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.	3 score on a scale Standard Deviation .94	3 score on a scale Standard Deviation .82

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	enLighten Laser Picosecond Pulse n=10 participants at risk Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment	enLighten Laser Nanosecond Pulse n=10 participants at risk Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
Skin and subcutaneous tissue disorders Erythema	100.0% 10/10 • Number of events 10 • 12 weeks	100.0% 10/10 • Number of events 10 • 12 weeks
Skin and subcutaneous tissue disorders Edema	100.0% 10/10 • 12 weeks	100.0% 10/10 • 12 weeks
Skin and subcutaneous tissue disorders Purpura	50.0% 5/10 • 12 weeks	50.0% 5/10 • 12 weeks

Cutera

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