Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System

Last updated: August 18, 2025
Sponsor: Candela Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Skin Aging

Treatment

Profound Matrix

Clinical Study ID

NCT06157567
PFX22003
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick SkinType I - VI.

  2. Willing to receive Profound Matrix treatments with any of the following applicators:Sublime, Sublative RF, and/or Matrix Pro applicator

  3. Able and willing to comply with the treatment/follow-up schedule and comply with allstudy (protocol) requirements.

  4. Willing to provide signed, informed consent to participate in the study

  5. Willing to have photographs and images taken of the treated areas to be used inevaluations, publications, presentations, and marketing materials (Subject identitywill be masked).

Exclusion

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 priorto enrollment into the study, and/or breast feeding

  2. Pacemaker or internal defibrillator or any active electrical implant anywhere in thebody

  3. Superficial metal or other implants in the treatment area, except superficial dentalimplants, unless these implants can be removed or covered with rolled gauze duringtreatment

  4. Skin cancer in the treatment area or history of melanoma

  5. History of current cancer and subject has undergone chemotherapy within the last 12months

  6. Severe concurrent conditions, such as cardiac disorders

  7. Impaired immune system or use of immunosuppressive medications

  8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following aprophylactic 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 wellas 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 topicalanesthetic (e.g. lidocaine)

  14. History of systemic corticosteroid 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, orfat injections or other methods of augmentation with injected bio-material in thetreated area within the last 3 months

  20. Permanent synthetic fillers (e.g. silicone) in the treatment area

  21. Absorbable facial threads within the last 1 year or non-absorbable facial threadswithin the intended treatment area

  22. In the opinion of the Investigator, the subject is unwilling or unable to adhere tothe study requirements or is otherwise unsuitable for the study

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Profound Matrix
Phase:
Study Start date:
May 24, 2022
Estimated Completion Date:
May 24, 2028

Study Description

The Profound Matrix system is a multipurpose (3-in-1) radiofrequency (RF) platform. The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro applicator for aesthetic treatments including its cleared indications of wrinkles, acne scars, striae, and electrocoagulation and hemostasis. The Sublime and Sublative RF applicators are equivalent to those on the European conformity (CE) marked eLos, eTwo, eMatrix device family. The Matrix Pro applicator utilizes micro-needling technology and is new feature of the Profound Matrix system. The Profound Matrix system, including the Matrix Pro applicator are currently cleared for use in the US under FDA 510k K211217. This study aims to evaluate additional indications for treatment through the electrocoagulation and hemostasis mechanism of action for dermal remodeling and improvement in skin conditions to provide study subjects with a safe and effective alternative treatment that can be performed with minimal risks and decreased downtime. Eligible subjects would be healthy adult volunteers between 18 to 75 years of age seeking clinical treatment for indications as listed above. The research is sponsored by Candela Corporation and planned to be conducted at up to 20 sites globally. From the first subject enrollment to the last subject follow-up, the expected total duration is up to 5 years across all sites. The participants will undergo informed consent, screening and enrollment, treatments for the indication to be treated, and follow-up visits at no cost. The data from this research will assist Candela in optimizing treatment parameters, treatment guidelines, providing input to clinical education and marketing material, and support the research and development of micro-needling technology alongside energy-based devices.

Connect with a study center

  • Waterfront Skin and Laser

    Vancouver,
    Canada

    Site Not Available

  • Waterfront Skin and Laser

    Vancouver 6173331,
    Canada

    Site Not Available

  • Candela European Institue of Excellence

    Madrid, 28830
    Spain

    Site Not Available

  • Candela European Institue of Excellence

    Madrid 3117735, 28830
    Spain

    Site Not Available

  • Center for Morden Aesthetic Medicine

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Center for Morden Aesthetic Medicine

    Jacksonville 4160021, Florida 4155751 32207
    United States

    Site Not Available

  • Candela Institue for Excellence

    Marlborough, Massachusetts 01752
    United States

    Site Not Available

  • Candela Institue for Excellence

    Marlborough 4943170, Massachusetts 6254926 01752
    United States

    Site Not Available

  • Concierge Medical Arts

    Fayetteville, North Carolina 28306
    United States

    Site Not Available

  • Concierge Medical Arts

    Fayetteville 4466033, North Carolina 4482348 28306
    United States

    Site Not Available

  • Gerrish MedEsthetics

    Vienna, Virginia 22180
    United States

    Site Not Available

  • Gerrish MedEsthetics

    Vienna 4791160, Virginia 6254928 22180
    United States

    Site Not Available

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