Functional Usability and Feasibility Testing of the Profound Matrixâ„¢ System (NCT06192550) | Clinical Trial Compass
CompletedNot Applicable
Functional Usability and Feasibility Testing of the Profound Matrixâ„¢ System
United States, Israel193 participantsStarted 2020-10-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance