An interventional study of Microlens Array in Wrinkles and Scars, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.
Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Device: Microlens Array
Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Physician's Global Assessment of Improvement
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
Time frame: 12 weeks post final treatment
| Milestone | Treatment With Microlens Array |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
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
| score on a scale | Treatment With Microlens Array |
|---|---|
| Physician's Global Assessment of Improvement | 2 ± 0.76 |
Collected over 12 weeks post final treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Microlens Array | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | Treatment With Microlens Array |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 7/7 |
| PetechiaeSkin and subcutaneous tissue disorders | 4/7 |
| EdemaSkin and subcutaneous tissue disorders | 3/7 |
| Age, Categorical(Participants) | Treatment With Microlens Array |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Treatment With Microlens Array |
|---|---|
| Female | 5 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Treatment With Microlens Array |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Cutera Inc.