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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01775293
Eligibility Criteria:
Inclusion Criteria:
* Subjects who had soft tissue sagging around nasolabial fold
* Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
* Subjects who voluntary decided to participate in the study and signed the informed consent
Exclusion Criteria:
* Subjects who have a skin disease on the face
* Subjects who have severe facial skin disease
* Subjects who are constantly taking anti-coagulants including aspirin
* Subjects who have too thin or thick skin
* Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
* Subjects who had an allergy to non-absorbable material.
* Subjects who are taking immune suppressants
* General weakness status
* Pregnant or lactating women
* Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
* Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
* Subjects who participated in other clinical trial within 30 days from screening
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01775293
Study Brief:
Protocol Section:
NCT01775293