Clinical Study to Evaluate the Safety and Efficacy of Matrix Pro Applicator Treatment to Lift the Eyebrow and Lift Lax Tissue in the Submentum and Neck
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laxity; Skin
- Sponsor
- Candela Corporation
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Improvements in lifting of lax tissue
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
Prospective, non-randomized, multi-center, pivotal clinical trial
Detailed Description
This is a two-arm study. Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment. Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
- •Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.
- •Willing to receive Matrix treatments with The Matrix Pro applicator.
- •Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
- •Willingness to provide signed, informed consent to participate in the study.
- •Willing to abstain from neuromodulators, injectable fillers and any aesthetic procedure which may resurface the skin and/or modify the dermal tissue throughout the entire study duration.
- •Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
- •Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.
- •Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials.
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, internal defibrillator, or any active electrical implant anywhere in the body.
- •Superficial metal or other implants in the treatment area, unless these implants can be removed or covered with rolled gauze during treatment, except superficial dental implants.
- •Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
- •Weight has fluctuated +/- 8lbs within the past year.
- •Skin cancer in the treatment area or history of melanoma.
- •History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
- •Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).
- •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 initiation of a prophylactic regimen.
Outcomes
Primary Outcomes
Improvements in lifting of lax tissue
Time Frame: 3 months post last treatment
as assessed by independent masked evaluators of pre and post treatment images