Functional Usability and Feasibility Testing of the Profound Matrix™ System

February 11, 2025 updated by: Candela Corporation
This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Yoqne'am 'Illit, Israel
        • Syneron Medical
  • United States
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Candela Institue for Excellence
    • New York
      • New York, New York, United States, 10028
        • NY Derm
      • New York City, New York, United States, 10128
        • OPTISKIN
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Laser & Vein Specialists of the Carolinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy Male or Female
  2. Age 18 to 75
  3. Subjects seeking treatment for facial, abdominal, or back wrinkles reduction, skin texture improvement and/or acne scars appearance improvement and willing to undergo RF treatments for improvement
  4. Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
  5. Willingness to provide signed, informed consent to participate in the study
  6. Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
  2. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
  3. Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment
  4. Current skin cancers in the treatment area or history of melanoma
  5. History of current cancer and subject has undergone chemotherapy within the last 12 months
  6. Severe concurrent conditions, such as cardiac disorders
  7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
  8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
  9. Poorly controlled endocrine disorders such as diabetes
  10. Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
  11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
  12. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
  13. Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
  14. Patients on systemic corticosteroid therapy in past six months
  15. Is taking medication(s) for which sunlight is a contraindication
  16. Tattoos or permanent makeup in the intended treatment area
  17. Excessively tanned skin
  18. Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
  19. Subject has hair and is unwilling to have hair removed from the treatment area
  20. Subjects has undergone facelift in the last 12 months
  21. Subject has undergone aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months) within the intended to treat area
  22. Subject has undergone Botox in the treatment area within the last 3 months
  23. Subject has non-permanent filler in the last 3 months within the intended to treat area
  24. Subject has permanent filler (e.g. silicone) within the intended to treat area
  25. Subject has absorbable facial threads within the last 2 years within the intended to treat area
  26. Subject has non-absorbable facial threads within the intended to treat area aa. Subject is using a topical in the treatment area that the Investigator's deems the subject unsuitable for the study.

bb. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Matrix Pro
Subjects undergoing treatment with the Matrix Pro applicator.
Device: Profound Matrix™ System
Study subjects will be treated with the Profound Matrix System
Experimental: Group 2: Sublime/Sublative
Subjects undergoing treatment with either 1) Sublime applicator only, 2) Sublative RF applicator only, 3) Combined treatment of Sublime and Sublative RF applicators.
Device: Profound Matrix™ System
Study subjects will be treated with the Profound Matrix System
Experimental: Modified Matrix Pro
Subjects undergoing treatment with a Matrix Pro Modified applicator with lower RF power settings.
Device: Profound Matrix™ System
Study subjects will be treated with the Profound Matrix System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
Time Frame: 3 months post final treatment
Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by investigator at study endpoint
3 months post final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
Time Frame: 3 months post final treatment
Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by subject at study endpoint
3 months post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Candela Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Konika Schallen, MD, Candela Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUFT2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Scars - Mixed Atrophic and Hypertrophic

Clinical Trials on Profound Matrix™ System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings