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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02119793
Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects who have completed the LG-HACL014 study
* Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study
* Accept the obligation not to receive any other mid facial procedures or treatments during the study
* Signed informed consent
* Those who fall under one of the following 3 cases
1. Males or females who are surgically sterile
2. Post-Menopausal females who are above 45 years of age and 2 years after the last menstruation
3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the repeat treatment of the investigational device to avoid pregnancy
Exclusion Criteria:
* Have a history of hypertrophic scars or keloids
* Other criteria as identified in the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02119793
Study Brief:
Protocol Section:
NCT02119793