Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System

August 18, 2025 updated by: Candela Corporation
This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

The Profound Matrix system is a multipurpose (3-in-1) radiofrequency (RF) platform. The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro applicator for aesthetic treatments including its cleared indications of wrinkles, acne scars, striae, and electrocoagulation and hemostasis. The Sublime and Sublative RF applicators are equivalent to those on the European conformity (CE) marked eLos, eTwo, eMatrix device family. The Matrix Pro applicator utilizes micro-needling technology and is new feature of the Profound Matrix system. The Profound Matrix system, including the Matrix Pro applicator are currently cleared for use in the US under FDA 510k K211217. This study aims to evaluate additional indications for treatment through the electrocoagulation and hemostasis mechanism of action for dermal remodeling and improvement in skin conditions to provide study subjects with a safe and effective alternative treatment that can be performed with minimal risks and decreased downtime. Eligible subjects would be healthy adult volunteers between 18 to 75 years of age seeking clinical treatment for indications as listed above. The research is sponsored by Candela Corporation and planned to be conducted at up to 20 sites globally. From the first subject enrollment to the last subject follow-up, the expected total duration is up to 5 years across all sites. The participants will undergo informed consent, screening and enrollment, treatments for the indication to be treated, and follow-up visits at no cost. The data from this research will assist Candela in optimizing treatment parameters, treatment guidelines, providing input to clinical education and marketing material, and support the research and development of micro-needling technology alongside energy-based devices.

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 (Estimated)

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.
500

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Vancouver, Canada
        • Waterfront Skin and Laser
  • Spain
      • Madrid, Spain, 28830
        • Candela European Institue of Excellence
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Center for Morden Aesthetic Medicine
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Candela Institue for Excellence
    • North Carolina
      • Fayetteville, North Carolina, United States, 28306
        • Concierge Medical Arts
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Gerrish MedEsthetics

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 female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
  2. Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
  3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
  4. Willing to provide signed, informed consent to participate in the study
  5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).

Exclusion Criteria:

Any of the following will exclude the subject from the study:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, 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. Skin cancer 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 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 poorly controlled diabetes
  10. Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
  11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
  12. History of collagen vascular disease or vasculitic disorders
  13. Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
  14. History of systemic corticosteroid therapy in past six months
  15. Tattoos or permanent makeup in the intended treatment area
  16. Excessively tanned skin
  17. Facelift in the last 12 months
  18. Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
  19. Neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months
  20. Permanent synthetic fillers (e.g. silicone) in the treatment area
  21. Absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area
  22. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study

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: N/A
  • Interventional Model: Single Group 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: Treatment Group
Study subjects may be treated with any of the Profound Matrix applicators: Sublime, Sublative RF and/or Matrix Pro. Treatments may include combination of applicators or additional commercial devices per PI discretion.
Device: Profound Matrix
Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).

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
Standardized Clinical Photography
Time Frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Clinical photography will be taken of treated areas at baseline prior to treatment and all treatment and follow-up visits.
From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Numerical Rating Scale (NRS)
Time Frame: From the first treatment to the third treatment, up to 16 weeks.
Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.
From the first treatment to the third treatment, up to 16 weeks.
Investigator Global Aesthetic Improvement Scale (IGAIS)
Time Frame: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Investigator Global Aesthetic Improvement Scale (IGAIS) will be assessed at each follow-up visit with score -1 to 3 and corresponding ratings: -1 means worse, 0 means no change, 1 means improved, 2 means much improved, 3 means very much improved.
At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Subject Satisfaction Scale
Time Frame: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Subject satisfaction rating of improvement in indication will be obtained at each follow-up visit. The subject satisfaction scale scores from -2 to 2 with corresponding improvement rate: -2 means very dissatisfied, -1 means somewhat satisfied, 0 means neutral, 1 means somewhat satisfied, 2 means very satisfied.
At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Post-treatment Assessment Severity Scale
Time Frame: From the first treatment to the third treatment, up to 16 weeks.
Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.
From the first treatment to the third treatment, up to 16 weeks.

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 Institue for Exellence

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.
May 24, 2022

Primary Completion (Estimated)

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.
May 24, 2027

Study Completion (Estimated)

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.
May 24, 2028

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).
November 16, 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 4, 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.
December 6, 2023

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.
August 22, 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.
August 18, 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.
August 1, 2025

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.
  • PFX22003

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.

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