Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment (NCT06726122) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Netherlands, United Kingdom60 participantsStarted 2025-01-28
Plain-language 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.
Who can participate
Age range18 Years – 84 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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
What they're measuring
1
Evaluation of change in facial, submentum, and neck laxity
Timeframe: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.