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Completed

NCT Number: NCT01066026

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

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.

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Key information

Conditions

Wrinkles

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyaluronic acid with metallic cannula or standard needle.

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.

Other names: Restylane

Hyaluronic acid injected with the new tool.

Drug

hyaluronic acid with metallic cannula.

Other names: Restylane

Primary outcomes

  1. Number of Participants With Haematoma

    Time frame: Day 1; day 3; day 7; day 90

    Number of participants with haematoma at each visit

  2. Number of Participants With Erythema

    Time frame: Day 1; day 3; day 7; day 90

    Number of participants with erythema at each visit

Secondary outcomes

  1. Modified Fitzpatrick Wrinkle Scale (MFWS)

    Time frame: 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

  2. Global Aesthetic Improvement Scale

    Time frame: 90 days

    • 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

Sponsors and collaborators

Lead sponsor

Hexsel Dermatology Clinic

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2010
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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