Restylane® for the Treatment of Tear Trough Deformity

NCT04486794 | Completed

• 1 other identifier: 2020-Res-TT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tear Trough Eyelid Deformity

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Adverse events

  Baseline to end of study (up to week 10)

Study Arms (2)

Treatment at baseline

EXPERIMENTAL

Device: Restylane®

Treatment at Month 1

ACTIVE COMPARATOR

Device: Restylane®

Interventions

Restylane® DEVICE

Hyaluronic acid

Treatment at Month 1; Treatment at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Location

Study Officials

• Andreas Nikolis, FRCSC

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: July 7, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)