Evaluating the Profound Matrix System for skin treatments

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

This study is testing a new skin treatment system to see if it can safely improve wrinkles, acne scars, and loose skin for healthy adults aged 18 to 75.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Candela Corporation (industry)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Jacksonville, Florida and 5 other locations)
• Trial ID: NCT06157567 on ClinicalTrials.gov

What this trial studies

This clinical trial is a non-randomized, multi-center, open-label evaluation of the Profound Matrix system, a radiofrequency platform designed for aesthetic treatments. It aims to assess the safety and performance of various applicators, including Sublime, Sublative RF, and Matrix Pro, for conditions such as wrinkles, acne scars, and skin laxity. The study will involve healthy adult volunteers aged 18 to 75, who will receive treatments and undergo follow-up assessments over a period of up to 5 years. The goal is to provide a safe and effective alternative for skin condition treatments with minimal risks and downtime.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 75 with Fitzpatrick Skin Type I - VI seeking treatment for skin laxity, wrinkles, or other related conditions.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer patients a new, effective treatment option for improving skin conditions with reduced recovery time.

How similar studies have performed: Other studies using radiofrequency technology for skin treatments have shown promising results, indicating that this approach may be effective.

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

Where this trial is running

Jacksonville, Florida and 5 other locations

• Center for Morden Aesthetic Medicine — Jacksonville, Florida, United States (RECRUITING)
• Candela Institue for Excellence — Marlborough, Massachusetts, United States (RECRUITING)
• Concierge Medical Arts — Fayetteville, North Carolina, United States (COMPLETED)
• Gerrish MedEsthetics — Vienna, Virginia, United States (RECRUITING)
• Waterfront Skin and Laser — Vancouver, Canada (RECRUITING)
• Candela European Institue of Excellence — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Konika Schallen, MD — Candela Institue for Exellence
• Study coordinator: Maya J Duffy

Conditions: Skin Laxity, Wrinkle, Skin Condition