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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06219278
• Other study ID #: MXP23001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 29, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: May 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Wrinkle

Intervention

Device:
• Profound Matrix
The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks

Locations

Country	Name	City	State
Israel	Syneron Medical	Yoqne'am 'Illit
United States	Candela Institue for Excellence	Marlborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Approximately 6 months following baseline assessment
Secondary	Subject Global Aesthetic Improvement Scale (GAIS)	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)	Approximately 6 months following baseline assessment
Secondary	Subject Global Aesthetic Improvement Scale (GAIS)	Assessment of Subject Assessment of Improvement via GAIS ratings at follow up timepoint using a 5-point scale (-1= worse to 3= very much improved)	Approximately 4 months following baseline assessment