Trial Outcomes & Findings for Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment (NCT NCT03424148)

Last Updated: 2023-09-14

Results Overview

Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

6 or 12 weeks after the final treatment

Results posted on

2023-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Excel V™ Laser & Micro-Lens Array Attachment Treatment with Excel V™ Laser and a Micro-Lens Array Attachment
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Excel V™ Laser & Micro-Lens Array Attachment n=10 Participants Treatment with Excel V™ Laser and a Micro-Lens Array Attachment
Age, Continuous	53.1 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	10 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 or 12 weeks after the final treatment

Outcome measures

Outcome measures
Measure	Excel V™ Laser & Micro-Lens Array Attachment n=8 Participants Treatment with Excel V™ Laser and a Micro-Lens Array Attachment
Study Effectiveness for Skin Aesthetic Improvement	1.25 score on a scale Standard Deviation 0.71

Adverse Events

Excel V™ Laser & Micro-Lens Array Attachment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Excel V™ Laser & Micro-Lens Array Attachment n=10 participants at risk Treatment with Excel V™ Laser and a Micro-Lens Array Attachment
Skin and subcutaneous tissue disorders Erythema	100.0% 10/10 • 12 weeks post final treatment, up to 9 months
Skin and subcutaneous tissue disorders Edema	90.0% 9/10 • 12 weeks post final treatment, up to 9 months
Skin and subcutaneous tissue disorders Purpura	10.0% 1/10 • 12 weeks post final treatment, up to 9 months

Additional Information

Margout Doucette

Cutera

Phone: 415-656-9612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place