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Active, not recruitingNCT06726122Updated Nov 2, 2026

Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment

An interventional study of Profound Matrix in Skin Laxity, Wrinkle and Skin Condition, sponsored by Candela Corporation. Active, not recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 84 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 recruitingGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 84 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Skin Laxity
  • Wrinkle
  • Skin Condition

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03

In context

Skin Diseases

496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 375 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

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.

Browse Candela studies →

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

04

Who can participate

Ages eligible
18 Years to 84 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 84 years of age with Fitzpatrick Skin Type I - VI.
  2. Willing to receive Profound Matrix treatments with Matrix Pro applicator
  3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
  4. Willing to provide signed, to participate in the study
  5. 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).

Exclusion criteria

Exclusion Criteria:

Any of the following will exclude the subject from the study:

  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 or internal defibrillator or any active electrical implant anywhere in the body
  3. 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
  4. Skin cancer in the treatment area or history of melanoma
  5. History of current cancer and/or subject has undergone chemotherapy within the last 12 months
  6. Severe concurrent conditions, such as cardiac disorders
  7. Impaired immune system or use of medications, except for topical products and inhaler medications per investigator discretion
  8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
  9. Poorly controlled endocrine disorders such as poorly controlled diabetes
  10. Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
  11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
  12. History of collagen vascular disease or vasculitic disorders
  13. Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g., lidocaine)
  14. History of systemic therapy in past six months
  15. Tattoos or permanent makeup in the intended treatment area
  16. Excessively tanned skin
  17. Facelift in the last 12 months
  18. Aesthetics treatments/procedures (e.g., facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
  19. 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
  20. Permanent synthetic fillers (e.g., silicone) in the intended treatment area
  21. Absorbable facial threads within the last 12 months or non-absorbable facial threads within the intended treatment area
  22. 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
Terms in these criteria, in plain language(3)

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

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Matrix Pro Treatment Group

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

    Device: Profound Matrix

Interventions

  • DeviceProfound Matrix

    Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.

07

Study locations

3 sites
  • Kliniek voor Esthetische Geneeskunde
    Amsterdam, EK 1017, Netherlands
  • Illuminate Skin & Wellness Clinic
    Kings Hill, Kent ME19 4DG, United Kingdom
  • GHB Clinic
    London, WC2H 9HE, United Kingdom
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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jan 2028, 36 months after the start.

Of 53 industry-sponsored interventional studies with no phase under Skin Diseases, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's planned 36 months is above that.

Counting every sponsor, half of 95 studies reached it within 7 months; a quarter within 2 and three quarters within 22.

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

Registered
Dec 3, 2024
First posted
Dec 10, 2024
StartActual
Jan 28, 2025
Primary completionEst.
Jan 2028
CompletionEst.
May 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
Show all 1 update
  1. Nov 2, 2026
    Enrolling by invitation→Active, not recruiting
    + 2 other changes: verification date and index terms

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
NCT06726122
Lead sponsor
Candela Corporation
Responsible party
Sponsor
First posted
Dec 10, 2024
Start date
Jan 28, 2025
Primary completion
Jan 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Konika Schallen, MD
study director · Candela Corporation

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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Discussion

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