Restylane® for the Treatment of Tear Trough Deformity

Not Applicable

Completed

• Conditions: Tear Trough Eyelid Deformity
• Interventions: Device: Restylane®

• Registration Number: NCT04486794
• Lead Sponsor: Erevna Innovations Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-07
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-07
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment at baseline	Restylane®	-
Treatment at Month 1	Restylane®	-

Primary Outcome Measures

Name	Time	Method
GAIS	1 month	Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change).

Secondary Outcome Measures

Name	Time	Method
Adverse events	Baseline to end of study (up to week 10)	Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.

Trial Locations

Locations (1)

Erevna Innovations Inc; 🇨🇦 Montreal, Quebec, Canada