Restylane® for the Treatment of Tear Trough Deformity

A Clinical Evaluation of the Efficacy and Safety of Hyaluronic Acid (Restylane®) for the Treatment of Tear Trough Deformity

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

Study Overview

• Status: Completed
• Conditions: Tear Trough Eyelid Deformity
• Intervention / Treatment: Device: Restylane®

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3R 3A1
      • Erevna Innovations Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment at baseline	Device: Restylane®; Hyaluronic acid
Active Comparator: Treatment at Month 1	Device: Restylane®; Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAIS	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).	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.
• Investigators: Principal Investigator: Andreas Nikolis, FRCSC, Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2020-Res-TT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No