Trial Outcomes & Findings for Study of a Novel Laser for Skin Rejuvenation (NCT NCT02910492)

NCT ID: NCT02910492

Last Updated: 2023-09-15

Results Overview

Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 weeks post-final treatment, an average of 4 months
• Results posted on: 2023-09-15

Participant Flow

Participant milestones

Measure	Investigational Enlighten Device Laser treatment for facial skin rejuvenation with the experimental enLighten Laser
Overall Study STARTED	10
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a Novel Laser for Skin Rejuvenation

Baseline characteristics by cohort

Measure	Investigational Enlighten Device n=10 Participants Laser treatment for facial skin rejuvenation with the experimental enLighten Laser
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 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	2 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, an average of 4 months

Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).

Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing

1= Mild Clearing 0= No Clearing

Outcome measures

Measure	Investigational Enlighten Device n=4 Participants Laser treatment for facial skin rejuvenation with the experimental enLighten Laser
Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).	1.7 score on a scale Standard Deviation 1.5

Adverse Events

Investigational Enlighten Device

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Investigational Enlighten Device n=10 participants at risk Laser treatment for facial skin rejuvenation with the experimental enLighten Laser
Skin and subcutaneous tissue disorders Erythema	100.0% 10/10 • 12 weeks post final treatment, up to 6 months
Skin and subcutaneous tissue disorders Edema	80.0% 8/10 • 12 weeks post final treatment, up to 6 months

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