See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Age at least 18 years
* Ability to understand the informed consent process
* Written informed consent is given prior to performing any study procedure
* Moderate to severe changes of the jawline as per the Merz Jawline Scale (Grade 3 or 4)
* Moderate to severe changes of the décolletage as per the Merz Decollete scale (Grade 3 or 4)
* Presence of prominent platysmal bands
* Presence of horizontal necklace lines is not mandatory for inclusion but, if present, will be assessed on a 5 point scale
* Moderate to severe laxity of neck and decollete skin
* Body mass index (BMI) less than or equal to 30 kg/m2 at screening
* Female subjects are not pregnant (negative urine pregnancy test) and are willing to minimize the chance of becoming pregnant during the study period and follow up.
* Willing and able as assessed by the PI to follow study instruction and likely to complete all study assessments and required visits
* Willing to allow photographs to be used for educational and marketing purposes including on the internet and social media
Exclusion Criteria:
* • Age greater than 65 years
* Platysma neck bands at rest or excessively loose skin in lower face, neck, and décolletage area that, in the opinion of the Principal investigator (PI) or Subinvestigator (SI), may interfere with assessment
* Presence of thyroid enlargement, neck masses, salivary gland pathology, scars, or other features of the lower face/neck/décolletage area (…