WrinkleNCT06192550
Functional Usability and Feasibility Testing of the Profound Matrix™ System
A study testing Profound Matrix™ System in people with Wrinkle and Acne Scars - Mixed Atrophic and Hypertrophic, run by Candela Corporation at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- Profound Matrix™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Oct 2020to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Male or Female
- Age 18 to 75
- 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
- Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
- Willingness to provide signed, informed consent to participate in the study
- Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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
- Current skin cancers in the treatment area or history of melanoma
- History of current cancer and subject has undergone chemotherapy within the last 12 months
- Severe concurrent conditions, such as cardiac disorders
Show all 27Show fewer
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, 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 diabetes
- Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
- History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
- Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
- Patients on systemic corticosteroid therapy in past six months
- Is taking medication(s) for which sunlight is a contraindication
- Tattoos or permanent makeup in the intended treatment area
- Excessively tanned skin
- 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.
- Subject has hair and is unwilling to have hair removed from the treatment area
- Subjects has undergone facelift in the last 12 months
- 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
- Subject has undergone Botox in the treatment area within the last 3 months
- Subject has non-permanent filler in the last 3 months within the intended to treat area
- Subject has permanent filler (e.g. silicone) within the intended to treat area
- Subject has absorbable facial threads within the last 2 years within the intended to treat area
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Candela Institue for Excellence
Marlborough, Massachusetts, 01752
NY Derm
New York, New York, 10028
OptiSkin
New York, New York, 10128
About this study
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.
- Being tested
- Profound Matrix™ System
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profound Matrix™ SystemDevice
Study subjects will be treated with the Profound Matrix System
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Matrix Pro | Experimental | Subjects undergoing treatment with the Matrix Pro applicator. Receives: Device: Profound Matrix™ System |
| Group 2: Sublime/Sublative | Experimental | Subjects undergoing treatment with either 1) Sublime applicator only, 2) Sublative RF applicator only, 3) Combined treatment of Sublime and Sublative RF applicators. Receives: Device: Profound Matrix™ System |
| Modified Matrix Pro | Experimental | Subjects undergoing treatment with a Matrix Pro Modified applicator with lower RF power settings. Receives: Device: Profound Matrix™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
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
Measured: 3 months post final treatment
Secondary outcomes (1)
Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
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
Measured: 3 months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 Oct 2020
- Primary completion27 Sep 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Schallen, MD, Principal investigator, Candela Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192550
- Sponsor's protocol ID
- FUFT2002
- Status last verified
- Oct 2024
- First submitted
- 21 Dec 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Usability and Feasibility Testing of the Profound Matrix™ System
- ClinicalTrials.gov ID
- NCT06192550
- Acronym / sponsor ID
- FUFT2002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 5 Jan 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Matrix Pro | Experimental | Device: Profound Matrix™ SystemSubjects undergoing treatment with the Matrix Pro applicator. |
| Group 2: Sublime/Sublative | Experimental | Device: Profound Matrix™ SystemSubjects undergoing treatment with either 1) Sublime applicator only, 2) Sublative RF applicator only, 3) Combined treatment of Sublime and Sublative RF applicators. |
| Modified Matrix Pro | Experimental | Device: Profound Matrix™ SystemSubjects undergoing treatment with a Matrix Pro Modified applicator with lower RF power settings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy Male or Female
- Age 18 to 75
- 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
- Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
- Willingness to provide signed, informed consent to participate in the study
Key exclusion criteria (27 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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
- Current skin cancers 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 Matrix™ SystemStudy subjects will be treated with the Profound Matrix System | Device | Group 1: Matrix Pro, Group 2: Sublime/Sublative, Modified Matrix Pro |
Primary outcome
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
1 secondary outcome
Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
Time frame: 3 months post final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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 Medical
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profound Matrix™ System in people with Wrinkle and Acne Scars - Mixed Atrophic and Hypertrophic, run by Candela Corporation at 5 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 6 inclusion and 27 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance (time frame: 3 months post final treatment). 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 13 Feb 2025.