Functional Usability and Feasibility Testing of the Profound Matrix™ System

Completed · Not applicable

Conditions studied: Wrinkle, Acne Scars - Mixed Atrophic and Hypertrophic

In brief

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.

Key facts

Study ID

NCT06192550

Run by

Candela Corporation

People needed

193

Starts

2020-10-28

Expected to finish

2023-12-29

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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
• Tattoos or permanent makeup in the intended treatment area
• Excessively tanned skin
• Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
• Subject has hair and is unwilling to have hair removed from the treatment area
• Subjects has undergone facelift in the last 12 months
• Subject has undergone aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months) within the intended to treat area
• Subject has undergone Botox in the treatment area within the last 3 months
• Subject has non-permanent filler in the last 3 months within the intended to treat area
• Subject has permanent filler (e.g. silicone) within the intended to treat area
• Subject has absorbable facial threads within the last 2 years within the intended to treat area

Where it is running

• Candela Institue for Excellence — Marlborough, Massachusetts, United States
• NY Derm — New York, New York, United States
• OptiSkin — New York, New York, United States
• Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States
• Syneron Medical — Yokneam Illit, Israel

Full record on ClinicalTrials.gov

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