Clinical trial NCT01066026: Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wrinkles
Keywords: metallic cannula
Hyaluronic acid
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Haematoma
timeFrame: Day 1; day 3; day 7; day 90
measure: Number of Participants With Erythema
timeFrame: Day 1; day 3; day 7; day 90
Secondary outcomes:
measure: Modified Fitzpatrick Wrinkle Scale (MFWS)
timeFrame: Baseline and 90 days
measure: Global Aesthetic Improvement Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Brazilian Center for Studies in Dermatology
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro Brasileiro de Estudos em Dermatologia
Study officials:
affiliation: CBED
name: Doris Hesxel, MD
role: PRINCIPAL_INVESTIGATOR
References: