An interventional study of Excel V™ Laser & Micro-Lens Array Attach in Scarring and Skin Aging, sponsored by Cutera Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Other
Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V laser at 1064 nm and 532 nm for the improvement of skin quality.
This is an open-label, prospective, study in approximately 60 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of rhytides, lentigines, pigmentation, erythema, telangiectasia, pore size and skin texture. Subjects may undergo a 2mm punch biopsy a treatment area up to 72 hours post treatment and at a designated follow-up period per Investigator discretion. Subjects will receive laser treatments. Subjects will return to the site after final study treatment for two follow-up visits: 6 and 12 weeks.
Exclusion Criteria:
Treatment with Excel V™ Laser and a Micro-Lens Array Attachment for skin quality
Device: Excel V™ Laser & Micro-Lens Array Attach
Subjects will receive laser treatments
Study Effectiveness for Skin Aesthetic Improvement
Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean
Time frame: 6 or 12 weeks after the final treatment
| Milestone | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean
| score on a scale | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Study Effectiveness for Skin Aesthetic Improvement | 1.25 ± 0.71 |
Collected over 12 weeks post final treatment, up to 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Excel V™ Laser & Micro-Lens Array Attachment | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Event | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 10/10 |
| EdemaSkin and subcutaneous tissue disorders | 9/10 |
| PurpuraSkin and subcutaneous tissue disorders | 1/10 |
| Age, Continuous(years) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Mean | 53.1 ± 15.4 |
| Sex: Female, Male(Participants) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| Female | 9 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Excel V™ Laser & Micro-Lens Array Attachment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Cutera Inc.