Trial Outcomes & Findings for Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment (NCT NCT03430921)
NCT ID: NCT03430921
Last Updated: 2023-09-26
Results Overview
An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment
COMPLETED
NA
4 participants
Baseline, and at 12 weeks post final treatment (up to 30 weeks)
2023-09-26
Participant Flow
Participant milestones
| Measure |
Enlighten™ Laser and a MLA Attachment
Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment
Baseline characteristics by cohort
| Measure |
Enlighten™ Laser and a MLA Attachment
n=4 Participants
Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, and at 12 weeks post final treatment (up to 30 weeks)An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment
Outcome measures
| Measure |
Enlighten™ Laser and a MLA Attachment
n=2 Participants
Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment
|
|---|---|
|
Acne Scarring Improvement
Baseline Acne Scar Assessment Scale Score
|
4 score on a scale
Standard Deviation 0
|
|
Acne Scarring Improvement
12 weeks post final treatment Acne Scar Assessment Scale Score
|
4 score on a scale
Standard Deviation 0
|
Adverse Events
Enlighten™ Laser and a MLA Attachment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enlighten™ Laser and a MLA Attachment
n=4 participants at risk
Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
4/4 • 12 weeks post-final treatment, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Edema
|
50.0%
2/4 • 12 weeks post-final treatment, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Discomfort
|
50.0%
2/4 • 12 weeks post-final treatment, up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place