Functional Usability and Feasibility Testing of the Profound Matrix™ System

NCT06192550 | Completed FDA Device

• 1 other identifier: FUFT2002
• Study Type: interventional
• Target: 193
• Locations: 2 countries
• Sites: 5

Brief Summary

This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.

Conditions

Wrinkle; Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (1)

• Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance

  Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by investigator at study endpoint

  3 months post final treatment

Secondary Outcomes (1)

• Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance

  3 months post final treatment

Study Arms (3)

Group 1: Matrix Pro

EXPERIMENTAL

Subjects undergoing treatment with the Matrix Pro applicator.

Device: Profound Matrix™ System

Group 2: Sublime/Sublative

EXPERIMENTAL

Subjects undergoing treatment with either 1) Sublime applicator only, 2) Sublative RF applicator only, 3) Combined treatment of Sublime and Sublative RF applicators.

Device: Profound Matrix™ System

Modified Matrix Pro

EXPERIMENTAL

Subjects undergoing treatment with a Matrix Pro Modified applicator with lower RF power settings.

Device: Profound Matrix™ System

Interventions

Profound Matrix™ System DEVICE

Study subjects will be treated with the Profound Matrix System

Group 1: Matrix Pro; Group 2: Sublime/Sublative; Modified Matrix Pro

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 Male or Female
• Age 18 to 75
• Subjects seeking treatment for facial, abdominal, or back wrinkles reduction, skin texture improvement and/or acne scars appearance improvement and willing to undergo RF treatments for improvement
• Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
• Willingness to provide signed, informed consent to participate in the study
• Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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
• Current skin cancers 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 due to immunosuppressive diseases such as AIDS and HIV, 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 diabetes
• Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
• History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
• Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
• Patients on systemic corticosteroid therapy in past six months
• Is taking medication(s) for which sunlight is a contraindication

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (5)

Candela Institue for Excellence

Marlborough, Massachusetts, 01752, United States

Location

NY Derm

New York, New York, 10028, United States

Location

OptiSkin

New York, New York, 10128, United States

Location

Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Syneron Medical

Yokneam Illit, Israel

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Konika Schallen, MD

  Candela Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: October 28, 2020
• Primary Completion: September 27, 2023
• Study Completion: December 29, 2023
• Last Updated: February 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IL (1)