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

Brazilan Center for Studies in Dermatology

Status and phase: Completed; Phase 2

Conditions: Wrinkles

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01066026

08-CBED08-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Metallic cannula

Experimental group

Description:

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

Treatment:

Procedure: hyaluronic acid with metallic cannula or standard needle.

Drug: Hyaluronic acid injected with the new tool.

Standard needle

Active Comparator group

Description:

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

Treatment:

Procedure: hyaluronic acid with metallic cannula or standard needle.