A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles

Not Applicable

Completed

• Conditions: Wrinkle
• Interventions: Device: Profound Matrix

• Registration Number: NCT06219278
• Lead Sponsor: Candela Corporation

Brief Summary

This is a retrospective chart review of data from the multi-site prospective clinical trial, "Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)" to evaluate the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of wrinkles.

Detailed Description

This was a retrospective medical record review of subject data from the source study FUFT2002 to evaluate the safety, efficacy, tolerability, and usability of the Profound MatrixTM System with the Matrix Pro Applicator for the treatment of wrinkles.

Study Timeline

• Study Start: 2023-10-29
• Study First Submitted: 2023-12-21
• Primary Completion: 2023-12-29
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Study Completion: 2024-07-01
• Results First Submitted: 2024-08-20
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-12
• Results First Posted: 2024-09-19
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending).
2. Received full face treatment with 27W Matrix Pro applicator only.
3. Have baseline and follow-up assessments obtained.
4. Have photography obtained with the VISIA standardized camera system (Appendix III).

Exclusion Criteria

1. Sun exposure during the course of the study.
2. Aesthetic procedures and/or treatments during the course of the study.
3. Any violation of study treatment instructions.
4. Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression).
5. Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matrix Pro Applicator	Profound Matrix	Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W)

Primary Outcome Measures

Name	Time	Method
Improvement in Facial Wrinkles	Approximately 6 months following baseline assessment	Improvement in the appearance of wrinkles was assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment). Success for an individual subject (an individual responder) was determined if at least two out of three evaluators correctly identified the post-treatment photograph by selecting the correct corresponding photograph side (left or right).

Secondary Outcome Measures

Name	Time	Method
Subject Global Aesthetic Improvement Scale (GAIS)	Approximately 6 months following baseline assessment	Assessment of Subject Assessment of Improvement via GAIS ratings at the study endpoint (3MFU) using a 5-point scale (-1= worse to 3= very much improved)
Subject Global Aesthetic Improvement Scale (SGAIS)	Approximately 4 months following baseline assessment	Assessment of Subject Assessment of Improvement via GAIS ratings at a study timepoint using a 5-point scale (-1= worse to 3= very much improved)

Trial Locations

Locations (2)

Candela Institue for Excellence; 🇺🇸 Marlborough, Massachusetts, United States

Syneron Medical; 🇮🇱 Yoqne'am 'Illit, Israel