N/A
N=32
A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
Wrinkle
Bottom Line
View on ClinicalTrials.gov: NCT06219278 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Improvement in Facial Wrinkles — 24 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Profound Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Candela Corporation
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Facial Wrinkles |
24 | — |
| SECONDARY Subject Global Aesthetic Improvement Scale (GAIS) |
4; 13; 13; 2; 0 | — |
| SECONDARY Subject Global Aesthetic Improvement Scale (SGAIS) |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06219278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.