Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Laxity
- Sponsor
- Candela Corporation
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Evaluation of change in facial, submentum, and neck laxity
- Status
- Enrolling By Invitation
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
Investigators
Eligibility Criteria
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
- •Any of the following will exclude the subject from the study:
- •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
- •Impaired immune system or use of immunosuppressive medications, except for topical products and inhaler medications per investigator discretion
- •Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- •Poorly controlled endocrine disorders such as poorly controlled diabetes
Outcomes
Primary Outcomes
Evaluation of change in facial, submentum, and neck laxity
Time Frame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers.