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Trial Outcomes & Findings for A Study of a Novel Multi-Wavelength Laser for Tattoo Removal (NCT NCT02910505)

NCT ID: NCT02910505

Last Updated: 2023-09-21

Results Overview

Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing Higher scores indicate better outcomes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

6 weeks post-final treatment

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment
Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser for tattoo removal
Overall Study
STARTED
8
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of a Novel Multi-Wavelength Laser for Tattoo Removal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment
n=8 Participants
Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser for tattoo removal
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 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
1 Participants
n=5 Participants
Race (NIH/OMB)
White
7 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

Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing Higher scores indicate better outcomes

Outcome measures

Outcome measures
Measure
Treatment
n=1 Participants
Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser for tattoo removal
Tattoo Clearing as Rated by Investigator
4 score on a scale
Standard Deviation 0

Adverse Events

Treatment

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment
n=8 participants at risk
Treatment with investigational Cutera enlighten laser for tattoo removal enLighten Laser: Laser for tattoo removal
Skin and subcutaneous tissue disorders
Erythema
100.0%
8/8 • 12 weeks post final treatment, up to 9 months
Skin and subcutaneous tissue disorders
Edema
87.5%
7/8 • 12 weeks post final treatment, up to 9 months
Skin and subcutaneous tissue disorders
Purpura
12.5%
1/8 • 12 weeks post final treatment, up to 9 months

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Results disclosure agreements

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