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

Candela Corporation

Status: Completed

Conditions: Wrinkle

Treatments: Device: Profound Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT06219278

MXP23001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Matrix Pro Applicator

Description:

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

Treatment:

Device: Profound Matrix