Skin LaxityNCT06157567
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
A study testing Profound Matrix in people with Skin Laxity and Wrinkle, run by Candela Corporation at 6 sites in 3 countries.
Trial summary
This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Wrinkle, Skin Condition
- What is being tested?
- Profound Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 24 May 2022to 24 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
- Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
- Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
- Willing to provide signed, informed consent to participate in the study
- 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).
Who cannot join
- Any of the following will exclude the subject from the study:
- Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
- Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
- 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
- Skin cancer in the treatment area or history of melanoma
- History of current cancer and subject has undergone chemotherapy within the last 12 months
Show all 23Show fewer
- Severe concurrent conditions, such as cardiac disorders
- Impaired immune system or use of immunosuppressive medications
- Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- Poorly controlled endocrine disorders such as poorly controlled diabetes
- Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
- History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
- History of collagen vascular disease or vasculitic disorders
- Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
- History of systemic corticosteroid therapy in past six months
- Tattoos or permanent makeup in the intended treatment area
- Excessively tanned skin
- Facelift in the last 12 months
- Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
- 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
- Permanent synthetic fillers (e.g. silicone) in the treatment area
- Absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Concierge Medical Arts
Fayetteville, North Carolina, 28306
Center for Morden Aesthetic Medicine
Jacksonville, Florida, 32207
Candela Institue for Excellence
Marlborough, Massachusetts, 01752
Gerrish MedEsthetics
Vienna, Virginia, 22180
About this study
This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.
Read the 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.
- Conditions
- Skin Laxity, Wrinkle, Skin Condition
- Being tested
- Profound Matrix
- Medical subject headings
- Cutis Laxa, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profound MatrixDevice
Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Profound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Clinical Photography
Clinical photography will be taken of treated areas at baseline prior to treatment and all treatment and follow-up visits.
Measured: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Numerical Rating Scale (NRS)
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.
Measured: From the first treatment to the third treatment, up to 16 weeks.
Post-treatment Assessment Severity Scale
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.
Measured: From the first treatment to the third treatment, up to 16 weeks.
Investigator Global Aesthetic Improvement Scale (IGAIS)
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.
Measured: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Subject Satisfaction Scale
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.
Measured: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start24 May 2022
- Primary completion24 May 2027 (estimated)
- Study completion24 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Schallen, MD, Principal investigator, Candela Institue for Exellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157567
- Sponsor's protocol ID
- PFX22003
- Status last verified
- Aug 2025
- First submitted
- 16 Nov 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
- ClinicalTrials.gov ID
- NCT06157567
- Acronym / sponsor ID
- PFX22003
- Conditions
- Skin Laxity, Wrinkle, Skin Condition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 24 May 2028 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
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 non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Profound MatrixStudy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
- Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
- Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
- Willing to provide signed, informed consent to participate in the study
- 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).
Key exclusion criteria (23 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
- Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
- 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
- Skin cancer in the treatment area or history of melanoma
- History of current cancer and subject has undergone chemotherapy within the last 12 months
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 MatrixTreatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks). | Device | Treatment Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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 Schallen, MD principal investigator
Candela Institue for Exellence
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profound Matrix in people with Skin Laxity and Wrinkle, run by Candela Corporation at 6 sites in 3 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 5 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Standardized Clinical Photography (time frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.). The study lists 5 primary outcomes in all. 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 22 Aug 2025.