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Restylane® for the Treatment of Tear Trough Deformity

E

Erevna Innovations

Status

Completed

Conditions

Tear Trough Eyelid Deformity

Treatments

Device: Restylane®

Study type

Interventional

Funder types

Other

Identifiers

NCT04486794
2020-Res-TT

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

42 participants in 2 patient groups

Treatment at baseline
Experimental group
Treatment:
Device: Restylane®
Treatment at Month 1
Active Comparator group
Treatment:
Device: Restylane®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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