Comparison of Safety and Efficacy of a Metallic Cannula Versus a Standard Needle to Inject Hyaluronic Acid for Nasolabial Fold - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasolabial Fold	Device: Injection of hyaluronic acid in nasolabial folds	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:

Modified Fitzpatrick Wrinkle Scale [ Time Frame: visit 5 - 90 days ] [ Designated as safety issue: No ]
Inflammatory signs [ Time Frame: visit 5 - 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Global Improvement Assessment [ Time Frame: visit 5 - 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	July 2009
Study Completion Date:	March 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Metallic cannula	Device: Injection of hyaluronic acid in nasolabial folds 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.
Active Comparator: Standard needle	Device: Injection of hyaluronic acid in nasolabial folds 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.

Arms

Assigned Interventions

Experimental: Metallic cannula

Device: Injection of hyaluronic acid in nasolabial folds

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.

Active Comparator: Standard needle

Device: Injection of hyaluronic acid in nasolabial folds

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066026

Locations

Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil, 90570-040

Sponsors and Collaborators

Brazilan Center for Studies in Dermatology

More Information

Additional Information:

Brazilian Center for Studies in Dermatology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:	NCT01066026 History of Changes
Other Study ID Numbers:	08-CBED08-02
Study First Received:	January 26, 2010
Last Updated:	November 22, 2010
Health Authority:	Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency

Keywords provided by Brazilan Center for Studies in Dermatology:

metallic cannula
Hyaluronic acid

Additional relevant MeSH terms:

Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013