Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity

NCT06640998 | Enrolling By Invitation FDA Device

• 1 other identifier: MXP24001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, non-randomized, multi-center, pivotal clinical trial

Conditions

Laxity; Skin

Keywords

Laxity; Brow Lift; Neck Lift; Sagging; Skin tightening

Outcome Measures

Primary Outcomes (1)

• Improvements in lifting of lax tissue

  as assessed by independent masked evaluators of pre and post treatment images

  3 months post last treatment

Study Arms (2)

Zone 1: Eyebrow Lift

EXPERIMENTAL

Treatment of the upper face including treatment of forehead to mid cheek

Device: Matrix Pro

Zone 2: Submentum and Neck

EXPERIMENTAL

Treatment of the lower face including mid to low cheek, submentum, and neck

Device: Matrix Pro

Interventions

Matrix Pro DEVICE

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

Zone 1: Eyebrow Lift; Zone 2: Submentum and Neck

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.
• Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.
• Willing to receive Matrix treatments with The Matrix Pro applicator.
• Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
• Willingness to provide signed, informed consent to participate in the study.
• Willing to abstain from neuromodulators, injectable fillers and any aesthetic procedure which may resurface the skin and/or modify the dermal tissue throughout the entire study duration.
• Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
• Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.
• Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3-months prior to enrollment into the study, and/or breast feeding.
• Pacemaker, internal defibrillator, or any active electrical implant anywhere in the body.
• Superficial metal or other implants in the treatment area, unless these implants can be removed or covered with rolled gauze during treatment, except superficial dental implants.
• Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
• Weight has fluctuated +/- 8lbs within the past year.
• Skin cancer in the treatment area or history of melanoma.
• History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
• Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).
• 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 initiation of a prophylactic regimen.
• Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and/or severe active inflammatory acne.
• History of abnormal wound healing, keloid, or hypertrophic scar formation.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders.
• Known allergy to medication to be used during treatments such as lidocaine, benzocaine, tetracaine, Xylocaine, or Pro-Nox™ (a 50% oxygen and 50% nitrous oxide mixture (laughing gas).
• On systemic corticosteroid therapy in past six months.

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (1)

Candela Institute for Excellence

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)