- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01066026
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Porto Alegre, Brazil
- Centro Brasileiro de Estudos em Dermatologia
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90570-040
- Brazilian Center For Studies in Dermatology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metallic cannula
Nasolabial Fold with metallic cannula and hyaluronic acid injected.
hyaluronic acid with metallic cannula or standard needle.
Hyaluronic acid injected with the new tool
|
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:
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:
hyaluronic acid with metallic cannula.
Other Names:
|
Active Comparator: Standard needle
Nasolabial Fold with standard needle and hyaluronic acid injected.
hyaluronic acid with metallic cannula or standard needle.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Haematoma
Time Frame: Day 1; day 3; day 7; day 90
|
Number of participants with haematoma at each visit
|
Day 1; day 3; day 7; day 90
|
Number of Participants With Erythema
Time Frame: Day 1; day 3; day 7; day 90
|
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)
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
|
Baseline and 90 days
|
Global Aesthetic Improvement Scale
Time Frame: 90 days
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Doris Hesxel, MD, CBED
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-CBED08-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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