Status:
COMPLETED
Restylane® for the Treatment of Tear Trough Deformity
Lead Sponsor:
Erevna Innovations Inc.
Conditions:
Tear Trough Eyelid Deformity
Eligibility:
FEMALE
18+ years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
July 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04486794
Start Date
July 7 2019
End Date
December 31 2020
Last Update
February 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erevna Innovations Inc
Montreal, Quebec, Canada, H3R 3A1