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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07412392
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 19 to 75 years
* Voluntarily provided written informed consent
* Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 on both sides)
* Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
* Able to understand instructions and comply with study procedures
Exclusion Criteria:
* Active facial skin disease, infection, or untreated scars in the treatment area
* History of severe allergy or hypersensitivity to device components
* Facial aesthetic or invasive procedures in the treatment area within 6 months prior to screening
* Use of prohibited medications within required washout periods
* Participation in another interventional clinical trial within 4 weeks prior to screening or during the study
* Pregnancy, breastfeeding, or non-compliance with contraception requirements
* Any condition deemed inappropriate by the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT07412392
Study Brief:
Protocol Section:
NCT07412392