Restylane® for the Treatment of Tear Trough Deformity | NCT04486794

Studies
Restylane® for the Treatment of Tear Trough Deformity

NCT04486794

Sponsor

Erevna Innovations Inc.

Status

Completed

Last Update Posted

Feb 10, 2021Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Tear Trough Eyelid Deformity

Interventions

Restylane®

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2019Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2021

Last Update Posted Date

Feb 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Label	Type	Description	Intervention Names
Treatment at baseline	Experimental		Device: Restylane®
Treatment at Month 1	Active Comparator		Device: Restylane®

Name	Type	Description	Arm Group Labels	Other Names
Restylane®	Device	Hyaluronic acid	Treatment at Month 1 Treatment at baseline

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andreas Nikolis, FRCSC	Erevna Innovations Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Erevna Innovations Inc		Montreal	Quebec	H3R 3A1	Canada

Intervention 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.