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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02904057
Eligibility Criteria:
Inclusion Criteria:
1. Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
2. Is at least 18 years of age.
3. Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
4. Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
Exclusion Criteria:
1. Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
2. Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
3. Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
4. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
5. Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02904057
Study Brief:
Protocol Section:
NCT02904057