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Restylane® for the Treatment of Tear Trough Deformity | Clinical Trials | Clareo Health

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Restylane® for the Treatment of Tear Trough Deformity

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

NCT04486794•Erevna Innovations Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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®;
+5 more criteria

Locations (1)

Erevna Innovations Inc

Montreal, Quebec, Canada

Key Dates

Start Date

July 7, 2019

Primary Completion Date

December 30, 2020

Completion Date

December 31, 2020

Last Updated

February 10, 2021

Enrollment

ACTUAL participants

Conditions

Tear Trough Eyelid Deformity

Interventions

Restylane®

DEVICE