MedDataX Logo

Trial Outcomes & Findings for A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation (NCT NCT03421691)

NCT ID: NCT03421691

Last Updated: 2023-09-06

Results Overview

The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate 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

17 participants

Primary outcome timeframe

12 weeks post-final treatment

Results posted on

2023-09-06

Participant Flow

Participant milestones

Participant milestones
Measure
Excel V Laser
Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser
Overall Study
STARTED
16
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Excel V Laser
n=16 Participants
Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser
Age, Continuous
46.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male
Female
14 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
2 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 degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes * 4=Very Significant Improvement * 3=Significant Improvement * 2=Moderate Improvement * 1=Mild Improvement 0=No Change(

Outcome measures

Outcome measures
Measure
Excel V Laser
n=10 Participants
Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser
Degree of Improvement Rating at 12 Weeks Post-final Treatment
1.4 score on a scale
Standard Deviation 0.8

Adverse Events

Excel V Laser

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Excel V Laser
n=16 participants at risk
Treatment with the excel V Laser Genesis procedure utilizing 1064 nm laser
Skin and subcutaneous tissue disorders
Erythema
100.0%
16/16 • 12 weeks post-final treatment, up to 9 months
Skin and subcutaneous tissue disorders
Edema
12.5%
2/16 • 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