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Clinical Trials/NCT04486794
NCT04486794
Completed
Not Applicable

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

Erevna Innovations Inc.1 site in 1 country42 target enrollmentStarted: July 7, 2019Last updated:
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ConditionsTear Trough Eyelid Deformity

Overview

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
GAIS
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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®;

Outcomes

Primary Outcomes

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

  • Adverse events(Baseline to end of study (up to week 10))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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