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

NCT01066026 | Completed Phase 2 Results

• 1 other identifier: 08-CBED08-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

metallic cannula; Hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Haematoma

  Number of participants with haematoma at each visit

  Day 1; day 3; day 7; day 90

• Number of Participants With Erythema

  Number of participants with erythema at each visit

  Day 1; day 3; day 7; day 90

Secondary Outcomes (2)

• Modified Fitzpatrick Wrinkle Scale (MFWS)

  Baseline and 90 days

• Global Aesthetic Improvement Scale

  90 days

Study Arms (2)

Metallic cannula

EXPERIMENTAL

Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool

Procedure: hyaluronic acid with metallic cannula or standard needle.; Drug: Hyaluronic acid injected with the new tool.

Standard needle

ACTIVE COMPARATOR

Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.

Procedure: hyaluronic acid with metallic cannula or standard needle.

Interventions

hyaluronic acid with metallic cannula or standard needle. PROCEDURE

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.

Also known as: Restylane

Metallic cannula; Standard needle

Hyaluronic acid injected with the new tool. DRUG

hyaluronic acid with metallic cannula.

Also known as: Restylane

Metallic cannula

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
• Female subjects aged from 18 to 60
• Fitzpatrick phototype I to VI
• Presence of bilateral folds graded from 2 to 3 according to the Modified
• Fitzpatrick Wrinkle Scale
• Subjects that have never performed any treatment of nasolabial folds
• Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method
• Subjects who will be available throughout the duration of the study
• Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

You may not qualify if:

• Use of systemic corticosteroids
• History of herpes in lip
• Inflammation or active infection in the area to be injected
• Any surgical treatment or cosmetic procedure in the area to be injected that interfere in study's outcomes
• Coagulation disorders or use of anticoagulants
• Previous hypersensitivity responses to Hyaluronic acid.
• Pregnant or women in breastfeeding, or women planning to become pregnant

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (2)

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, 90570-040, Brazil

Location

Centro Brasileiro de Estudos em Dermatologia

Porto Alegre, Brazil

Location

MeSH Terms

Interventions

Hyaluronic Acid; Restylane

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Doris Hexsel
• Organization: Brazilian Center for Studies in Dermatology

cientifico@cbed.org.br

55 51 30262633

Study Officials

• Doris Hesxel, MD

  CBED

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: February 10, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 1, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-09

Locations

BR (2)