Trial Outcomes & Findings for A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles (NCT NCT06219278)

NCT ID: NCT06219278

Last Updated: 2024-10-08

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

Approximately 6 months following baseline assessment

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Matrix Pro Applicator Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Profound Matrix: The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Matrix Pro Applicator n=32 Participants Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Profound Matrix: The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Age, Continuous	50.53 years STANDARD_DEVIATION 10.99 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Region of Enrollment Israel	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 6 months following baseline assessment

Outcome measures

Outcome measures
Measure	Matrix Pro Applicator n=32 Participants Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Profound Matrix: The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Improvement in Facial Wrinkles	24 Participants

SECONDARY outcome

Timeframe: Approximately 6 months following baseline assessment

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)

Outcome measures

Outcome measures
Measure	Matrix Pro Applicator n=32 Participants Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Profound Matrix: The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Subject Global Aesthetic Improvement Scale (GAIS) Very Much Improved	4 Participants
Subject Global Aesthetic Improvement Scale (GAIS) Much Improved	13 Participants
Subject Global Aesthetic Improvement Scale (GAIS) Improved	13 Participants
Subject Global Aesthetic Improvement Scale (GAIS) No Change	2 Participants
Subject Global Aesthetic Improvement Scale (GAIS) Worse	0 Participants

SECONDARY outcome

Timeframe: Approximately 4 months following baseline assessment

Population: data was not collected and analyzed for this outcome

Assessment of Subject Assessment of Improvement via GAIS ratings at a study timepoint using a 5-point scale (-1= worse to 3= very much improved)

Outcome measures

Outcome data not reported

Adverse Events

Matrix Pro Applicator

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Matrix Pro Applicator n=32 participants at risk Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Profound Matrix: The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Immune system disorders Swelling	3.1% 1/32 • Number of events 1 • Adverse event data was collected for approximately 3 years from initiation of source study on October 27, 2020, until completion of this retrospective analysis on July 1, 2024.
Cardiac disorders Irregular Cardiac Rhythm	3.1% 1/32 • Number of events 1 • Adverse event data was collected for approximately 3 years from initiation of source study on October 27, 2020, until completion of this retrospective analysis on July 1, 2024.
Skin and subcutaneous tissue disorders Itchy bumps on skin	3.1% 1/32 • Number of events 1 • Adverse event data was collected for approximately 3 years from initiation of source study on October 27, 2020, until completion of this retrospective analysis on July 1, 2024.
Immune system disorders Herpetic Outbreak	3.1% 1/32 • Number of events 1 • Adverse event data was collected for approximately 3 years from initiation of source study on October 27, 2020, until completion of this retrospective analysis on July 1, 2024.
Skin and subcutaneous tissue disorders Erythema	3.1% 1/32 • Number of events 1 • Adverse event data was collected for approximately 3 years from initiation of source study on October 27, 2020, until completion of this retrospective analysis on July 1, 2024.

Additional Information

Katherine Coleman

Candela

Phone: 508-358-7400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place