ClinicalTrials.gg
Active, not recruitingNCT06640998Updated Nov 2, 2026

Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity

An interventional study of Matrix Pro in Laxity; Skin, sponsored by Candela Corporation. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Candela Corporation · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Laxity; Skin

Keywords

  • Laxity
  • Brow Lift
  • Neck Lift
  • Sagging
  • Skin tightening
03

In context

Lead sponsor

Candela Corporation is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
  2. Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.
  3. Willing to receive Matrix treatments with The Matrix Pro applicator.
  4. Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
  5. Willingness to provide signed, to participate in the study.
  6. 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.
  7. Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
  8. Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.
  9. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials.

Exclusion criteria

Exclusion Criteria:

  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, internal defibrillator, or any active electrical implant anywhere in the body.
  3. 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.
  4. Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
  5. Weight has fluctuated +/- 8lbs within the past year.
  6. Skin cancer in the treatment area or history of melanoma.
  7. History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
  8. Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).
  9. Impaired immune system due to diseases such as AIDS and , or use of immunosuppressive medications.
  10. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following initiation of a prophylactic regimen.
  11. Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and/or severe active inflammatory acne.
  12. History of abnormal wound healing, keloid, or hypertrophic scar formation.
  13. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders.
  14. 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).
  15. On systemic therapy in past six months.
  16. Currently taking anticoagulants.
  17. Tattoos in the intended treatment area
  18. Excessively tanned skin.
  19. Is unwilling to have hair shaved from the treatment area, if applicable.
  20. Facelift and/or neck lift in the last 12 months.
  21. Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area.
  22. 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.
  23. Permanent synthetic fillers (e.g. silicone) or non-absorbable threads in the treatment area.
  24. Absorbable facial threads within the last 2 years.
  25. 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Zone 1: Eyebrow Lift

    Treatment of the upper face including treatment of forehead to mid cheek

    Device: Matrix Pro

  • Experimental
    Zone 2: Submentum and Neck

    Treatment of the lower face including mid to low cheek, submentum, and neck

    Device: Matrix Pro

Interventions

  • DeviceMatrix Pro

    Study subjects received up to three (3) study treatments with the Matrix Pro applicator

06

What researchers measure

Primary outcomes

  1. Improvements in lifting of lax tissue

    as assessed by independent masked evaluators of pre and post treatment images

    Time frame: 3 months post last treatment

07

Study locations

1 site
  • Candela Institute for Excellence
    Marlborough, Massachusetts 01752, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2024 (actual). Primary completion is estimated for May 2027, 32 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Sep 2027 → May 2027 and completion Sep 2028 → Sep 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2024
First posted
Oct 15, 2024
StartActual
Sep 9, 2024
Primary completionEst.
May 2027was Sep 2027
CompletionEst.
Sep 2027was Sep 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Active, not recruiting
changed Nov 2, 2026
Primary completion
Sep 2027→May 2027
Nov 2, 2026
Study completion
Sep 2028→Sep 2027
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Enrolling by invitation→Active, not recruiting
    Primary completion Sep 2027→May 2027
    Study completion Sep 2028→Sep 2027
    + 3 other changes: index terms, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06640998
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Sep 9, 2024
Primary completion
May 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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