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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Device: Profound Matrix

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Yoqne'am 'Illit, Israel
    • Syneron Medical
• United States
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Candela Institue for Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Matrix Pro Applicator; Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W)	Device: Profound Matrix; The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in facial wrinkles	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)	Approximately 6 months following baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Aesthetic Improvement Scale (GAIS)	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)	Approximately 6 months following baseline assessment
Subject Global Aesthetic Improvement Scale (GAIS)	Assessment of Subject Assessment of Improvement via GAIS ratings at follow up timepoint using a 5-point scale (-1= worse to 3= very much improved)	Approximately 4 months following baseline assessment

Collaborators and Investigators

• Sponsor: Candela Corporation
• Investigators: Principal Investigator: Konika Patel Schallen, MD, Candela Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MXP23001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No