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

NCT06219278 | Completed Results FDA Device

• 1 other identifier: MXP23001
• Study Type: observational
• Target: 32
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• 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). 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).

  Approximately 6 months following baseline assessment

Secondary Outcomes (2)

• Subject Global Aesthetic Improvement Scale (GAIS)

  Approximately 6 months following baseline assessment

• Subject Global Aesthetic Improvement Scale (SGAIS)

  Approximately 4 months following baseline assessment

Study Arms (1)

Matrix Pro Applicator

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

Device: Profound Matrix

Interventions

Profound Matrix DEVICE

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

Matrix Pro Applicator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data was extracted from the records of 32 subjects previously enrolled in the source study who satisfied current study eligibility criteria, were aged 25-70 years, with Fitzpatrick Skin Types II-IV and had received full face treatments with the 27W Matrix Pro Applicator

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (2)

Candela Institue for Excellence

Marlborough, Massachusetts, 01752, United States

Location

Syneron Medical

Yokneam Illit, Israel

Location

Results Point of Contact

• Title: Katherine Coleman
• Organization: Candela

katherinec@candelamedical.com

508-358-7400

Study Officials

• Konika Patel Schallen, MD

  Candela Medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 23, 2024
• Study Start: October 29, 2023
• Primary Completion: December 29, 2023
• Study Completion: July 1, 2024
• Last Updated: October 8, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)