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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT00797459
Eligibility Criteria:
Inclusion Criteria:
* Subjects seeking augmentation therapy for correction of bilateral NLFs
* Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
* Subjects willing to give written informed consent to participate in the study
* Women of childbearing potential willing to use an acceptable form of birth control during the study period
Exclusion Criteria:
* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
* Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the NLF area
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00797459
Study Brief:
Protocol Section:
NCT00797459