NCT06640998

Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity

Clinical Study to Evaluate the Safety and Efficacy of Matrix Pro Applicator Treatment to Lift the Eyebrow and Lift Lax Tissue in the Submentum and Neck

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Prospective, non-randomized, multi-center, pivotal clinical trial

Detailed description

This is a two-arm study. Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment. Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.

Conditions

• Laxity; Skin

Interventions

Type	Name	Description
DEVICE	Matrix Pro	Study subjects received up to three (3) study treatments with the Matrix Pro applicator

Timeline

• Start date: 2024-09-09
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-10-15
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study