NCT03430921

Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment

Open-label, Prospective, Multicenter Study to Evaluate the Cutera Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate to Severe Acne Scars

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Detailed description

This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive laser treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will return to the site after all study treatments have been delivered for a follow-up visit at 12 weeks following their final study treatment.

Conditions

• Scarring
• Acne

Interventions

Type	Name	Description
DEVICE	Enlighten™ Laser and a MLA Attachment	Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment.

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2018-02-13
• Last updated: 2023-09-26
• Results posted: 2023-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study