NCT06192550

Functional Usability and Feasibility Testing of the Profound Matrix™ System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.

Conditions

• Wrinkle
• Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

Type	Name	Description
DEVICE	Profound Matrix™ System	Study subjects will be treated with the Profound Matrix System

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-09-27
• Completion: 2023-12-29
• First posted: 2024-01-05
• Last updated: 2025-02-13

Locations

5 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study