Clinical trial NCT04486794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tear Trough Eyelid Deformity
Lead sponsor: Erevna Innovations Inc.
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GAIS
timeFrame: 1 month
Secondary outcomes:
measure: Adverse events
timeFrame: Baseline to end of study (up to week 10)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Erevna Innovations Inc
state: Quebec
Study officials:
affiliation: Erevna Innovations Inc.
name: Andreas Nikolis, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: