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

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.

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.

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