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OpenTrials
Completed

NCT Number: NCT06192550

Functional Usability and Feasibility Testing of the Profound Matrix™ System

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syneron Medical, Yokneam Illit, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Subject has non-absorbable facial threads within the intended to treat area aa. Subject is using a topical in the treatment area that the Investigator's deems the subject unsuitable for the study.

bb. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements

Treatment and study plan

Profound Matrix™ System

Device

Study subjects will be treated with the Profound Matrix System

Primary outcomes

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

    Time frame: 3 months post final treatment

    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

Secondary outcomes

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

    Time frame: 3 months post final treatment

    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 subject at study endpoint

Sponsors and collaborators

Lead sponsor

Candela Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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