Trial Outcomes & Findings for Multi-Wavelength Laser Tattoo Removal Pivotal Study (NCT NCT02935660)

NCT ID: NCT02935660

Last Updated: 2023-09-26

Results Overview

Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 6 weeks post-final treatment, approximately 7 months after study start
• Results posted on: 2023-09-26

Participant Flow

Participant milestones

Measure	Treatment Treatment with investigational Cutera enlighten laser for tattoo removal
Overall Study STARTED	27
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Wavelength Laser Tattoo Removal Pivotal Study

Baseline characteristics by cohort

Measure	Treatment n=27 Participants Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Age, Continuous	38.7 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks post-final treatment, approximately 7 months after study start

Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment

Outcome measures

Measure	Treatment n=25 Participants Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Tattoo Clearing as Rated by Blinded Evaluator	21 Participants

SECONDARY outcome

Timeframe: 6 weeks post-final treatment, approximately 7 months after study start

Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes

Outcome measures

Measure	Treatment n=25 Participants Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).	3.43 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 weeks post-final treatment, approximately 7 months after study start

Outcome measures

Measure	Treatment n=13 Participants Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Subject Satisfaction Levels at 6 Weeks Post-final Treatment number of subjects reporting they were "extremely satisfied" or "satisfied" with level of clearing	9 Participants
Subject Satisfaction Levels at 6 Weeks Post-final Treatment number of subjects reporting they were neutral with level of clearing	4 Participants
Subject Satisfaction Levels at 6 Weeks Post-final Treatment number of subjects who said they would the investigational treatment again	11 Participants

SECONDARY outcome

Timeframe: Reported by subject at the end of each treatment visit, up to 5 months

Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.

Outcome measures

Measure	Treatment n=27 Participants Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Subject Pain During Treatment	4.2 score on a scale Standard Deviation 2.9

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=27 participants at risk Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser tattoo removal treatment
Skin and subcutaneous tissue disorders Erythema	100.0% 27/27 • Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months
Skin and subcutaneous tissue disorders Edema	100.0% 27/27 • Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months
Skin and subcutaneous tissue disorders Frosting	100.0% 27/27 • Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months
Skin and subcutaneous tissue disorders Crusting	48.1% 13/27 • Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Email: mdoucette@cutera.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place