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Restylane® for the Treatment of Tear Trough Deformity

Primary Purpose

Tear Trough Eyelid Deformity

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Restylane®

About this trial

This is an interventional treatment trial for Tear Trough Eyelid Deformity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female;
Age of 18 years or greater;
Indication for treatment of bilateral tear trough deformity;
Symmetry of tear trough deformity at baseline;
Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.

Exclusion Criteria:

Prior (<1 year) or planning to undergo any surgery in the corporal area of interest for study;
Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;
Diabetes mellitus type 1 or type 2;
Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
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);
Restylane® should not be used in any person who has hypersensitivity to any of the components of the product;
Active skin inflammation or infection in or near the treatment area;
Possessing any of the contraindications for use of Restylane®;
Septal fat herniation;
Severe elastosis (e.g., dermatochalasis);
Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment.
Use of tear trough injections in the last 12 months.
Use of anterior midface injections in the last 12 months.

Sites / Locations

Erevna Innovations Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment at baseline

Treatment at Month 1

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04486794

First Posted

July 22, 2020

Last Updated

February 7, 2021

Sponsor

Erevna Innovations Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04486794

Brief Title

Restylane® for the Treatment of Tear Trough Deformity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 7, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erevna Innovations Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tear Trough Eyelid Deformity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Patients in this current trial will initially be randomized to either needle or cannula injections, or no treatment (control; ratio 3:3:1, respectively). Subjects will proceed from randomization in parallel assignment. Subjects initially randomized to the control group at Baseline will be randomized to either needle or cannula treatment at Visit 3, Month 1 (crossover). Subjects in the crossover group will then be seen at weeks 2 and 4 post last treatment, as per Schedule 1.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment at baseline

Arm Type

Experimental

Arm Title

Treatment at Month 1

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Restylane®

Intervention Description

Hyaluronic acid

Primary Outcome Measure Information:

Title

GAIS

Description

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).

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Adverse events

Description

Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.

Time Frame

Baseline to end of study (up to week 10)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female; Age of 18 years or greater; Indication for treatment of bilateral tear trough deformity; Symmetry of tear trough deformity at baseline; Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure. Exclusion Criteria: Prior (<1 year) or planning to undergo any surgery in the corporal area of interest for study; Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments; Diabetes mellitus type 1 or type 2; Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments; Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; 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); Restylane® should not be used in any person who has hypersensitivity to any of the components of the product; Active skin inflammation or infection in or near the treatment area; Possessing any of the contraindications for use of Restylane®; Septal fat herniation; Severe elastosis (e.g., dermatochalasis); Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment. Use of tear trough injections in the last 12 months. Use of anterior midface injections in the last 12 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Nikolis, FRCSC

Organizational Affiliation

Erevna Innovations Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erevna Innovations Inc

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3R 3A1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Restylane® for the Treatment of Tear Trough Deformity

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