NCT06726122

Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment

Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.

Detailed description

Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion

Conditions

• Skin Laxity
• Wrinkle
• Skin Condition

Interventions

Type	Name	Description
DEVICE	Profound Matrix	Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).

Timeline

• Start date: 2025-01-28
• Primary completion: 2028-01-01
• Completion: 2028-05-01
• First posted: 2024-12-10
• Last updated: 2025-06-15

Locations

3 sites across 2 countries: Netherlands, United Kingdom

Regulatory

• FDA-regulated device study