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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03911102
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
* Be outpatient, male or female subjects, in good general health, 18-65 years old
* Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
* Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Exclusion Criteria:
* Active skin disease, infections, or inflammation at the injection sites
* History of clinically significant bleeding disorders
* Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
* Planned or anticipated need for surgery or hospitalization through the end of the study
* Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03911102
Study Brief:
Protocol Section:
NCT03911102