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Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds

NCT01066026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-01

Study results available
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Summary

The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.

Conditions

  • Wrinkles

Interventions

PROCEDURE

hyaluronic acid with metallic cannula or standard needle.

The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices: * In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit; * In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit. Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.

DRUG

Hyaluronic acid injected with the new tool.

hyaluronic acid with metallic cannula.

Sponsors & Collaborators

  • Brazilan Center for Studies in Dermatology

    lead OTHER

Principal Investigators

  • Doris Hesxel, MD · CBED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01066026 on ClinicalTrials.gov