Wrinkle
Conditions
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.
Detailed 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.
Interventions
DEVICEProfound Matrix
The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
Sponsors
Candela Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Facial Wrinkles | Approximately 6 months following baseline assessment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (GAIS) | 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) |
| Subject Global Aesthetic Improvement Scale (SGAIS) | Approximately 4 months following baseline assessment | 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) |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Matrix Pro Applicator |
|---|---|
| Age, Continuous | 50.53 years STANDARD_DEVIATION 10.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment Israel | 13 participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 5 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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). 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).
Time frame: Approximately 6 months following baseline assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Matrix Pro Applicator | Improvement in Facial Wrinkles | 24 Participants |
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)
Time frame: Approximately 6 months following baseline assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Matrix Pro Applicator | Subject Global Aesthetic Improvement Scale (GAIS) | Very Much Improved | 4 Participants |
| Matrix Pro Applicator | Subject Global Aesthetic Improvement Scale (GAIS) | Much Improved | 13 Participants |
| Matrix Pro Applicator | Subject Global Aesthetic Improvement Scale (GAIS) | Improved | 13 Participants |
| Matrix Pro Applicator | Subject Global Aesthetic Improvement Scale (GAIS) | No Change | 2 Participants |
| Matrix Pro Applicator | Subject Global Aesthetic Improvement Scale (GAIS) | Worse | 0 Participants |
Secondary
Subject Global Aesthetic Improvement Scale (SGAIS)
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)
Time frame: Approximately 4 months following baseline assessment
Population: data was not collected and analyzed for this outcome