Skin LaxityNCT06726122
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
A study testing Profound Matrix in people with Skin Laxity and Wrinkle, run by Candela Corporation at 3 sites in 2 countries.
Trial summary
This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity. Read more about this study
- Who is it for?
- Ages 18 to 84 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
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Jan 2025to 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male subjects between 18 to 84 years of age with Fitzpatrick Skin Type I - VI.
- Willing to receive Profound Matrix treatments with 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 the 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/or 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, except for topical products and inhaler medications per investigator discretion
- 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, fat injections or other methods of augmentation with injected biomaterial in the intended treatment area within the last 3 months
- Permanent synthetic fillers (e.g., silicone) in the intended treatment area
- Absorbable facial threads within the last 12 months 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 study participation
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Illuminate Skin & Wellness Clinic
Kings Hill, Kent, ME19 4DG
GHB Clinic
London, WC2H 9HE
Netherlands1 site
Kliniek voor Esthetische Geneeskunde
Amsterdam, EK, 1017
About this study
Official title: Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity
This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.
Read the detailed description
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
- 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 |
|---|---|---|
| Matrix Pro Treatment Group | Experimental | Study subjects receive up to three (3) study treatments with the Matrix Pro applicator Receives: Device: Profound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change in facial, submentum, and neck laxity
Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers.
Measured: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start28 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionMay 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konika Schallen, MD, Study director, Candela Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726122
- Sponsor's protocol ID
- PFX22003_EU
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity
- ClinicalTrials.gov ID
- NCT06726122
- Acronym / sponsor ID
- PFX22003_EU
- Conditions
- Skin Laxity, Wrinkle, Skin Condition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Dec 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, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.
Detailed description
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix Pro Treatment Group | Experimental | Device: Profound MatrixStudy subjects receive up to three (3) study treatments with the Matrix Pro applicator |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female and male subjects between 18 to 84 years of age with Fitzpatrick Skin Type I - VI.
- Willing to receive Profound Matrix treatments with 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 the 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/or 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 | Matrix Pro Treatment Group |
Primary outcome
Evaluation of change in facial, submentum, and neck laxity
Time frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers.
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 2 Nov 2026.
- 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 study director
Candela Corporation
3 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 in people with Skin Laxity and Wrinkle, run by Candela Corporation at 3 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 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Netherlands. 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?
Evaluation of change in facial, submentum, and neck laxity (time frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.). 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 2 Nov 2026.