Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment

NCT06726122 | Enrolling By Invitation FDA Device

• 1 other identifier: PFX22003_EU
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.

Conditions

Skin Laxity; Wrinkle; Skin Condition

Outcome Measures

Primary Outcomes (1)

• Evaluation of change in facial, submentum, and neck laxity

  Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers.

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

Study Arms (1)

Matrix Pro Treatment Group

EXPERIMENTAL

Study subjects receive up to three (3) study treatments with the Matrix Pro applicator

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).

Matrix Pro Treatment Group

Eligibility Criteria

• Age: 18 Years - 84 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 84 years of age with Fitzpatrick Skin Type I - VI.
• Willing to receive Profound Matrix treatments with 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 the 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/or subject has undergone chemotherapy within the last 12 months
• Severe concurrent conditions, such as cardiac disorders
• Impaired immune system or use of immunosuppressive medications, except for topical products and inhaler medications per investigator discretion
• 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 (3)

Kliniek voor Esthetische Geneeskunde

Amsterdam, EK, 1017, Netherlands

Location

Illuminate Skin & Wellness Clinic

Kings Hill, Kent, ME19 4DG, United Kingdom

Location

GHB Clinic

London, WC2H 9HE, United Kingdom

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 Corporation

  STUDY DIRECTOR

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: December 3, 2024
• First Posted: December 10, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (2)