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OpenTrials
Completed

NCT Number: NCT04486794

Restylane® for the Treatment of Tear Trough Deformity

The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Restylane®

Device

Hyaluronic acid

Primary outcomes

  1. GAIS

    Time frame: 1 month

    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).

Secondary outcomes

  1. Adverse events

    Time frame: Baseline to end of study (up to week 10)

    Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits.

Sponsors and collaborators

Lead sponsor

Erevna Innovations Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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