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

NCT ID: NCT01066026

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

Detailed Description

This was a monocentric, prospective, randomized, phase II and double-blind study.

At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken.

On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be randomized.

Conditions

Wrinkles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metallic cannula

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

Group Type: EXPERIMENTAL

hyaluronic acid with metallic cannula or standard needle.

Intervention Type: 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.

Hyaluronic acid injected with the new tool.

Intervention Type: DRUG

hyaluronic acid with metallic cannula.

Standard needle

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

Group Type: ACTIVE_COMPARATOR

hyaluronic acid with metallic cannula or standard needle.

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Hyaluronic acid injected with the new tool.

hyaluronic acid with metallic cannula.

Intervention Type: DRUG

Other Intervention Names

Restylane; Restylane

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris Hesxel, MD

Role: PRINCIPAL_INVESTIGATOR

CBED

Locations

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Centro Brasileiro de Estudos em Dermatologia

Porto Alegre, , Brazil

Countries

Brazil

Other Identifiers

08-CBED08-02

Identifier Type: -

Identifier Source: org_study_id