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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-blind, Randomized and Controlled Clinical Trial to Compare Safety and Efficacy of a Metallic Cannula vs a Standard Needle for the Injection of Hyaluronic Acid Gel Dermal Filler (Restylane®) to Treat Nasolabial Folds

Conditions
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Wrinkles

Intervention / Treatment
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* Procedure: hyaluronic acid with metallic cannula or standard needle.
* Drug: Hyaluronic acid injected with the new tool.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metallic cannula<br>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.<br>* 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.<br>* Other names: Restylane;Drug: Hyaluronic acid injected with the new tool.<br>* hyaluronic acid with metallic cannula.<br>* Other names: Restylane;|
| Active Comparator: Standard needle<br>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.<br>* 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.<br>* Other names: Restylane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fitzpatrick Wrinkle Scale (MFWS) | 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 | Baseline and 90 days | 
| Global Aesthetic Improvement Scale | Very much improved: Optimal cosmetic result for the implant in this patient 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 | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metallic cannula, Hyaluronic acid