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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT03738020
Eligibility Criteria:
Inclusion Criteria:
1. Age: Women in 30\~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent.
Exclusion Criteria:
1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
2. Patients with a disorder in autoimmune system
3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.
5. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
6. Patients with a malignant tumor
7. Women in pregnancy or lactation
8. Hepatitis carriers or VDRL/HIV positive patients
9. Those with a hypersensitivity to the investigational medical device of this study
10. Other persons including those considered as difficult to perform this study by the principal investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT03738020
Study Brief:
Protocol Section:
NCT03738020