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

Phase 2

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Metallic cannula	Hyaluronic acid injected with the new tool.	Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool
Metallic cannula	hyaluronic acid with metallic cannula or standard needle.	Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool
Standard needle	hyaluronic acid with metallic cannula or standard needle.	Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Haematoma	Day 1; day 3; day 7; day 90	Number of participants with haematoma at each visit
Number of Participants With Erythema	Day 1; day 3; day 7; day 90	Number of participants with erythema at each visit

Secondary Outcome Measures

Name	Time	Method
Modified Fitzpatrick Wrinkle Scale (MFWS)	Baseline and 90 days	Class 0 - No visible wrinkles; continuous skin lines Class 0.5 - Very shallow yet visible wrinkles Class 1 - Fine wrinkles. Visible wrinkles and slight indentations Class 1.5 - Visible wrinkles and clear indentations,\<1-mm wrinkle depth\* Class 2 - Moderate wrinkles. Clearly visible wrinkles, 1- to 2-mm wrinkle depth\* Class 2.5 - Prominent and visible wrinkles; 2- to 3-mm wrinkle depth\* Class 3 - Deep wrinkles. Deep, furrowed wrinkle; \*\>3-mm wrinkle depth
Global Aesthetic Improvement Scale	90 days	1. Very much improved: Optimal cosmetic result for the implant in this patient 2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition

Locations (2): Brazilian Center for Studies in Dermatology
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Porto Alegre, Rio Grande Do Sul, Brazil
Centro Brasileiro de Estudos em Dermatologia
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Porto Alegre, Brazil