Trial Outcomes & Findings for Pilot Study of Multi-wavelength Laser for Tattoo Removal (NCT NCT03290547)

Results Overview

Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

6 weeks post-final treatment

Results posted on

2023-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cutera enLighten Laser Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.
Overall Study STARTED	22
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=22 Participants Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm. Cutera enLighten laser: Subjects will receive up to 10 laser treatments.
Age, Categorical <=18 years	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants
Sex: Female, Male Female	17 Participants n=22 Participants
Sex: Female, Male Male	5 Participants n=22 Participants

PRIMARY outcome

Timeframe: 6 weeks post-final treatment

Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes

Outcome measures

Outcome measures
Measure	Cutera enLighten Laser n=6 Participants Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.
Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator	2 score on a scale Standard Deviation 0.9

Adverse Events

All Enrolled Subjects

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=22 participants at risk Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.
Skin and subcutaneous tissue disorders Erythema	95.5% 21/22 • 12 weeks post final treatment, up to 15 months
Skin and subcutaneous tissue disorders Edema	100.0% 22/22 • 12 weeks post final treatment, up to 15 months
Skin and subcutaneous tissue disorders Frosting	90.9% 20/22 • 12 weeks post final treatment, up to 15 months

Additional Information

Margot Doucette

Cutera

Phone: 415-657-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place