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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01585220
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged between 30 and 75
2. Subjects who wanting to correct his/her nasolabial fold and attaining grade 3 or 4 in the Wrinkle Severity Rating Scale(WSRS) of nasolabial fold
3. Subjects whose nasolabial folds are visually symmetric
4. Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study
5. Subjects who can understand and comply with the instructions and all visit schedule
6. Subjects who voluntarily decided the participation of the study and signed the informed consent
Exclusion Criteria:
1. Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date
2. Subjects who had previous treatment at the lower orbital rim for wrinkle correction(e.g., face lift, soft tissue augmentation, medium depth peels, dermal photorejuvenation) within 6 months from screening date
3. Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date
4. Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area
5. Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area
6. Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid
7. Subjects who had a history of keloid formation or hypertrophic scar
8. Subjects who have a skin disorder or wound infection in the NLF area
9. Subjects who participated in other clinical trial within 30 days from screening date
10. The childbearing subjects who disagreed with medically acceptable contraception(e.g., condom, oral contraceptives continuing at least 3 months, contraceptives for injection or insertion, intrauterine contraceptive devices)
11. Pregnant or lactating subjects
12. Patients who are not eligible for this study at the medical discretion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT01585220
Study Brief:
Protocol Section:
NCT01585220