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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04486794
Eligibility Criteria:
Inclusion Criteria:
1. Female;
2. Age of 18 years or greater;
3. Indication for treatment of bilateral tear trough deformity;
4. Symmetry of tear trough deformity at baseline;
5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.
Exclusion Criteria:
1. Prior (\<1 year) or planning to undergo any surgery in the corporal area of interest for study;
2. Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;
3. Diabetes mellitus type 1 or type 2;
4. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
5. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
6. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
7. Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential);
8. Restylane® should not be used in any person who has hypersensitivity to any of the components of the product;
9. Active skin inflammation or infection in or near the treatment area;
10. Possessing any of the contraindications for use of Restylane®;
11. Septal fat herniation;
12. Severe elastosis (e.g., dermatochalasis);
13. Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment.
14. Use of tear trough injections in the last 12 months.
15. Use of anterior midface injections in the last 12 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04486794
Study Brief:
Protocol Section:
NCT04486794