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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT07145905
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult subjects over 18 years old seeking correction of the cheek area including fine lines.
* Subject scored grade 1 to 3 on the CFLDS.
* For women: not pregnant, not breast feeding
* Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and complete all required visits.
* Having given its signed informed consent.
Exclusion Criteria:
* Known hypersensitivity or previous allergic reaction to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
* History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
* Subject exhibits any physical attribute that may prevent assessment or treatment of the cheek area including fine lines as judged by the PI
* Clinically significant alcohol or drug abuse.
* Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
* Subject has unstable weight, as judged by the PI.
* Subject has no teeth or misses significant portion of dentition that changes the face appearance (subjects with dentures sufficiently replacing missing natural teeth are allowed).
* Subject under guardianship/tutorship
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07145905
Study Brief:
Protocol Section:
NCT07145905