WrinkleNCT06219278
A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
An observational study of Wrinkle, run by Candela Corporation at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Profound Matrix
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Oct 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Candela Institue for Excellence
Marlborough, Massachusetts, 01752
About this study
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.
Read the 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.
- Conditions
- Wrinkle
- Being tested
- Profound Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profound MatrixDevice
The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Matrix Pro Applicator | Source study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) Receives: Device: Profound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 6 months following baseline assessment
Secondary outcomes (2)
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)
Measured: Approximately 6 months following baseline assessment
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)
Measured: Approximately 4 months following baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start29 Oct 2023
- Primary completion29 Dec 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Patel Schallen, MD, Principal investigator, Candela Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219278
- Sponsor's protocol ID
- MXP23001
- Status last verified
- Sep 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
- ClinicalTrials.gov ID
- NCT06219278
- Acronym / sponsor ID
- MXP23001
- Conditions
- Wrinkle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix Pro Applicator | – | Device: Profound MatrixSource study subjects received up to three (3) full-face treatments for wrinkles with Matrix Pro Applicator (27W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profound MatrixThe source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks | Device | Matrix Pro Applicator |
Primary outcome
Improvement in Facial Wrinkles
Time frame: 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).
2 secondary outcomes
Subject Global Aesthetic Improvement Scale (GAIS)
Time frame: Approximately 6 months following baseline assessment
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: Approximately 4 months following baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konika Patel Schallen, MD principal investigator
Candela Medical
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkle, run by Candela Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Facial Wrinkles (time frame: Approximately 6 months following baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.