CompletedNot Applicable

Restylane® for the Treatment of Tear Trough Deformity

Canada42 participantsStarted 2019-07-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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;

What they're measuring

GAIS

Timeframe: 1 month

Trial details

NCT IDNCT04486794

SponsorErevna Innovations Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-30

View on ClinicalTrials.gov More Tear Trough Eyelid Deformity trials