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:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT04087395
Eligibility Criteria:
Inclusion Criteria:
1. Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
2. Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point WSRS).
3. Nasolabial folds of the same WSRS grade on the left and right sides of the face.
4. Able to follow study instructions and complete all required visits.
5. Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.
Exclusion Criteria:
1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
2. Known hypersensitivity or previous allergic reaction to any component of the study devices.
3. Use of a prohibited treatment/procedure within time periods defined in the protocol
4. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
6. History of connective tissue disease.
7. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
8. History of skin cancer in the treatment area.
9. Clinically active disease or infection in the NLF area.
10. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
11. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
12. Exposure to any other investigational drug/device within 90 days of entering the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04087395
Study Brief:
Protocol Section:
NCT04087395