NCT03424148

Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Scarring
• Skin Aging

Interventions

Type	Name	Description
DEVICE	Excel V™ Laser & Micro-Lens Array Attach	Subjects will receive laser treatments

Timeline

• Start date: 2018-02-20
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2018-02-06
• Last updated: 2023-09-14
• Results posted: 2023-09-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study