Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT01519206
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 30 to 65 years
* Subject in good health
* Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion Criteria:
* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01519206
Study Brief:
Protocol Section:
NCT01519206