Trial Outcomes & Findings for Study of a Novel Microlens Array Device for Skin Rejuvenation (NCT NCT02888626)

NCT ID: NCT02888626

Last Updated: 2023-08-15

Results Overview

Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 weeks post final treatment
• Results posted on: 2023-08-15

Participant Flow

Participant milestones

Measure	Treatment With Microlens Array Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a Novel Microlens Array Device for Skin Rejuvenation

Baseline characteristics by cohort

Measure	Treatment With Microlens Array n=7 Participants Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks post final treatment

Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator.

Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement

1= Moderate Improvement 0= Mild or No Improvement

Outcome measures

Measure	Treatment With Microlens Array n=7 Participants Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Physician's Global Assessment of Improvement	2 score on a scale Standard Deviation 0.76

Adverse Events

Treatment With Microlens Array

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment With Microlens Array n=7 participants at risk Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Skin and subcutaneous tissue disorders Erythema	100.0% 7/7 • 12 weeks post final treatment
Skin and subcutaneous tissue disorders Edema	42.9% 3/7 • 12 weeks post final treatment
Skin and subcutaneous tissue disorders Petechiae	57.1% 4/7 • 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