Restylane® for the Treatment of Tear Trough Deformity

Erevna Innovations

Status: Completed

Conditions: Tear Trough Eyelid Deformity

Treatments: Device: Restylane®

Study type: Interventional

Funder types: Other

Identifiers

NCT04486794

2020-Res-TT

Details and patient eligibility

About

The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Treatment at baseline

Experimental group

Treatment:

Device: Restylane®

Treatment at Month 1

Active Comparator group

Treatment:

Device: Restylane®