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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matrix Pro Applicator | Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound Matrix | Device | The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subject Global Aesthetic Improvement Scale (SGAIS) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Konika Patel Schallen, MD | Candela Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institue for Excellence | Marlborough | Massachusetts | 01752 | United States | ||
| Syneron Medical |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | Approximately 6 months following baseline assessment |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling | Immune system disorders | Non-systematic Assessment | Experienced swelling as suspected allergic reaction to an unknown allergen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Coleman | Candela | 508-358-7400 | 28533 | katherinec@candelamedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2023 | Aug 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2023 | Aug 20, 2024 | SAP_001.pdf |
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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) |
| Approximately 4 months following baseline assessment |
| Yokneam Illit |
| Israel |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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) | Posted | Count of Participants | Participants | Approximately 6 months following baseline assessment |
|
|
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| 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) | data was not collected and analyzed for this outcome | Posted | Approximately 4 months following baseline assessment |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 5 |
| 32 |
|
| Irregular Cardiac Rhythm | Cardiac disorders | Non-systematic Assessment | Experienced ?irregular cardiac rhythms via smartwatch and was evaluated by a cardiologist. Determined not related to study procedures |
|
| Itchy bumps on skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Herpetic Outbreak | Immune system disorders | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Closed, dry wound on the submentum and erythema in the right nasolabial folds following Tx. 1 complicated by subject picking at skin. |
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| No Change |
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| Worse |
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