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

NCT ID: NCT06157567

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2028-05-24

Brief Summary

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

Detailed 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.

Conditions

Skin Laxity; Wrinkle; Skin Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Study subjects may be treated with any of the Profound Matrix applicators: Sublime, Sublative RF and/or Matrix Pro. Treatments may include combination of applicators or additional commercial devices per PI discretion.

Group Type: EXPERIMENTAL

Profound Matrix

Intervention Type: DEVICE

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

Interventions

Profound Matrix

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type 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 all study (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 in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).

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 these 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 subject has undergone chemotherapy within the last 12 months

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 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 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, or fat injections or other methods of augmentation with injected bio-material in the treated 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 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 the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konika Schallen, MD

Role: PRINCIPAL_INVESTIGATOR

Candela Institue for Exellence

Locations

Center for Morden Aesthetic Medicine

Jacksonville, Florida, United States

Candela Institue for Excellence

Marlborough, Massachusetts, United States

Concierge Medical Arts

Fayetteville, North Carolina, United States

Gerrish MedEsthetics

Vienna, Virginia, United States

Waterfront Skin and Laser

Vancouver, , Canada

Candela European Institue of Excellence

Madrid, , Spain

Countries

United States; Canada; Spain

Other Identifiers

PFX22003

Identifier Type: -

Identifier Source: org_study_id