Laxity; SkinNCT06640998
Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity
A study testing Matrix Pro in people with Laxity; Skin, run by Candela Corporation at 1 site in United States.
Trial summary
Prospective, non-randomized, multi-center, pivotal clinical trial Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- Matrix Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to Sep 2027
- 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.
- Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.
- Willing to receive Matrix treatments with The Matrix Pro applicator.
- Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
- Willingness to provide signed, informed consent to participate in the study.
- Willing to abstain from neuromodulators, injectable fillers and any aesthetic procedure which may resurface the skin and/or modify the dermal tissue throughout the entire study duration.
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- Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
- Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.
- Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials.
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3-months prior to enrollment into the study, and/or breast feeding.
- Pacemaker, internal defibrillator, or any active electrical implant anywhere in the body.
- Superficial metal or other implants in the treatment area, unless these implants can be removed or covered with rolled gauze during treatment, except superficial dental implants.
- Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
- Weight has fluctuated +/- 8lbs within the past year.
- Skin cancer in the treatment area or history of melanoma.
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- History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
- Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).
- 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 initiation of a prophylactic regimen.
- Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and/or severe active inflammatory acne.
- History of abnormal wound healing, keloid, or hypertrophic scar formation.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders.
- Known allergy to medication to be used during treatments such as lidocaine, benzocaine, tetracaine, Xylocaine, or Pro-Nox™ (a 50% oxygen and 50% nitrous oxide mixture (laughing gas).
- On systemic corticosteroid therapy in past six months.
- Currently taking anticoagulants.
- Tattoos in the intended treatment area
- Excessively tanned skin.
- Is unwilling to have hair shaved from the treatment area, if applicable.
- Facelift and/or neck lift 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 soft-tissue and/or dermal filler, and/or fat injections or other methods of augmentation with injected biomaterial in the treated area within the last 6-months.
- Permanent synthetic fillers (e.g. silicone) or non-absorbable threads in the treatment area.
- Absorbable facial threads within the last 2 years.
- 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
1 site in 1 country.
United States1 site
Candela Institute for Excellence
Marlborough, Massachusetts, 01752
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of Matrix Pro Applicator Treatment to Lift the Eyebrow and Lift Lax Tissue in the Submentum and Neck
Prospective, non-randomized, multi-center, pivotal clinical trial
Read the detailed description
This is a two-arm study. Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment.
Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.
- Conditions
- Laxity; Skin
- Being tested
- Matrix Pro
- Keywords
- Laxity, Brow Lift, Neck Lift, Sagging, Skin tightening
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix ProDevice
Study subjects received up to three (3) study treatments with the Matrix Pro applicator
| Study group | Role | What they receive |
|---|---|---|
| Zone 1: Eyebrow Lift | Experimental | Treatment of the upper face including treatment of forehead to mid cheek Receives: Device: Matrix Pro |
| Zone 2: Submentum and Neck | Experimental | Treatment of the lower face including mid to low cheek, submentum, and neck Receives: Device: Matrix Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in lifting of lax tissue
as assessed by independent masked evaluators of pre and post treatment images
Measured: 3 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start9 Sep 2024
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640998
- Sponsor's protocol ID
- MXP24001
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 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 Safety and Efficacy of Matrix Pro Applicator Treatment to Lift the Eyebrow and Lift Lax Tissue in the Submentum and Neck
- ClinicalTrials.gov ID
- NCT06640998
- Acronym / sponsor ID
- MXP24001
- Conditions
- Laxity; Skin
- Keywords
- Laxity, Brow Lift, Neck Lift, Sagging, Skin tightening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Oct 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.
Prospective, non-randomized, multi-center, pivotal clinical trial
Detailed description
This is a two-arm study. Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment.
Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zone 1: Eyebrow Lift | Experimental | Device: Matrix ProTreatment of the upper face including treatment of forehead to mid cheek |
| Zone 2: Submentum and Neck | Experimental | Device: Matrix ProTreatment of the lower face including mid to low cheek, submentum, and neck |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
- Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.
- Willing to receive Matrix treatments with The Matrix Pro applicator.
- Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
- Willingness to provide signed, informed consent to participate in the study.
Key exclusion criteria (25 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, internal defibrillator, or any active electrical implant anywhere in the body.
- Superficial metal or other implants in the treatment area, unless these implants can be removed or covered with rolled gauze during treatment, except superficial dental implants.
- Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
- Weight has fluctuated +/- 8lbs within the past year.
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 |
|---|---|---|
| Matrix ProStudy subjects received up to three (3) study treatments with the Matrix Pro applicator | Device | Zone 1: Eyebrow Lift, Zone 2: Submentum and Neck |
Primary outcome
Improvements in lifting of lax tissue
Time frame: 3 months post last treatment
as assessed by independent masked evaluators of pre and post treatment images
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix Pro in people with Laxity; Skin, run by Candela Corporation at 1 site in United States.
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 9 inclusion and 25 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 1 site in United States. 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?
Improvements in lifting of lax tissue (time frame: 3 months post last 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 2 Nov 2026.