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

NCT06157567 | Active Not Recruiting FDA Device

• 1 other identifier: PFX22003
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Skin Laxity; Wrinkle; Skin Condition

Outcome Measures

Primary Outcomes (5)

• Standardized Clinical Photography

  Clinical photography will be taken of treated areas at baseline prior to treatment and all treatment and follow-up visits.

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

• Numerical Rating Scale (NRS)

  Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.

  From the first treatment to the third treatment, up to 16 weeks.

• Post-treatment Assessment Severity Scale

  Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.

  From the first treatment to the third treatment, up to 16 weeks.

• Investigator Global Aesthetic Improvement Scale (IGAIS)

  Investigator Global Aesthetic Improvement Scale (IGAIS) will be assessed at each follow-up visit with score -1 to 3 and corresponding ratings: -1 means worse, 0 means no change, 1 means improved, 2 means much improved, 3 means very much improved.

  At 1-month follow-up and 3-month follow-up, up to 14 weeks.

• Subject Satisfaction Scale

  Subject satisfaction rating of improvement in indication will be obtained at each follow-up visit. The subject satisfaction scale scores from -2 to 2 with corresponding improvement rate: -2 means very dissatisfied, -1 means somewhat satisfied, 0 means neutral, 1 means somewhat satisfied, 2 means very satisfied.

  At 1-month follow-up and 3-month follow-up, up to 14 weeks.

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

Device: Profound Matrix

Interventions

Profound Matrix DEVICE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
• Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
• Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
• Willing to provide signed, informed consent to participate in the study
• 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).

You may not qualify if:

• Any of the following will exclude the subject from the study:
• Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
• Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
• 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
• Skin cancer in the treatment area or history of melanoma
• History of current cancer and subject has undergone chemotherapy within the last 12 months
• Severe concurrent conditions, such as cardiac disorders
• Impaired immune system or use of immunosuppressive medications
• Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
• Poorly controlled endocrine disorders such as poorly controlled diabetes
• Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
• History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
• History of collagen vascular disease or vasculitic disorders
• Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
• History of systemic corticosteroid therapy in past six months

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (6)

Center for Morden Aesthetic Medicine

Jacksonville, Florida, 32207, United States

Location

Candela Institue for Excellence

Marlborough, Massachusetts, 01752, United States

Location

Concierge Medical Arts

Fayetteville, North Carolina, 28306, United States

Location

Gerrish MedEsthetics

Vienna, Virginia, 22180, United States

Location

Waterfront Skin and Laser

Vancouver, Canada

Location

Candela European Institue of Excellence

Madrid, 28830, Spain

Location

MeSH Terms

Conditions

Cutis Laxa; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Konika Schallen, MD

  Candela Institue for Exellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 6, 2023
• Study Start: May 24, 2022
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (4); CA (1); ES (1)