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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wrinkle

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Syneron Medical, Yokneam Illit, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Profound Matrix

Device

The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks

Primary outcomes

Improvement in Facial Wrinkles

Time frame: 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 outcomes

Subject Global Aesthetic Improvement Scale (GAIS)

Time frame: 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)

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Candela Corporation

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Jan 23, 2024
Registry last updated: Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed