Trial Outcomes & Findings for enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars (NCT NCT03284333)

NCT ID: NCT03284333

Last Updated: 2023-08-01

Results Overview

visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 12 weeks post-final treatment
• Results posted on: 2023-08-01

Participant Flow

Participant milestones

Measure	Treatment Treatment with the 1064nm laser
Overall Study STARTED	43
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars

Baseline characteristics by cohort

Measure	Treatment n=43 Participants Treatment with the 1064nm laser
Age, Continuous	39.6 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post-final treatment

Population: Number of patients who completed at least 1 treatment and the 12 week follow up visit

visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)

Outcome measures

Measure	Treatment n=33 Participants Treatment with the 1064nm laser
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.	31 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=43 participants at risk Treatment with the 1064nm laser
Skin and subcutaneous tissue disorders Erythema	100.0% 43/43 • Number of events 43 • Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment
Skin and subcutaneous tissue disorders Edema	83.7% 36/43 • Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment
Skin and subcutaneous tissue disorders Discomfort	37.2% 16/43 • Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment
Skin and subcutaneous tissue disorders Purpura	39.5% 17/43 • Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment

Additional Information

Margot Doucette

Cutera

Phone: 415-357-5518

Email: mdoucette@cutera.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place