Trial Outcomes & Findings for Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment (NCT NCT03424304)

NCT ID: NCT03424304

Last Updated: 2023-08-23

Results Overview

The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS). Higher scores mean better outcomes 4=Very Significant Improvement 3=Significant Improvement 2=Moderate Improvement 1=Mild Improvement 0=No Change

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 weeks post-final treatment
• Results posted on: 2023-08-23

Participant Flow

Participant milestones

Measure	Excel V™ Laser With Green Genesis Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment

Baseline characteristics by cohort

Measure	Excel V™ Laser With Green Genesis n=20 Participants Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	0 Participants n=5 Participants
Race (NIH/OMB) White	14 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: 12 weeks post-final treatment

The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS).

Higher scores mean better outcomes 4=Very Significant Improvement 3=Significant Improvement 2=Moderate Improvement

1=Mild Improvement 0=No Change

Outcome measures

Measure	Excel V™ Laser With Green Genesis n=19 Participants Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Global Aesthetic Improvement Scale Right side of the face	0.95 score on a scale Standard Deviation 1.40
Global Aesthetic Improvement Scale Left side of the face	1.05 score on a scale Standard Deviation 1.28

Adverse Events

Excel V™ Laser With Green Genesis

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Excel V™ Laser With Green Genesis n=20 participants at risk Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Skin and subcutaneous tissue disorders Erythema	100.0% 20/20 • Up to 12 weeks post-final treatment
Skin and subcutaneous tissue disorders Edema	60.0% 12/20 • Up to 12 weeks post-final treatment

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