Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction
NCT ID: NCT02006173
Last Updated: 2016-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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The study was estimated to be held one and half year including a 0-2 weeks screening period, a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF) severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets of randomized numbers are used, patient numbers and treatment numbers. Participants with odd patient numbers will be assigned to nasolabial group and those with even patient numbers will be assigned to nasolabial\&cheekbone group. Participants receive experiment treatment (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with normal saline) in the other side of the face randomly depending on the treatment numbers. Both physicians and participants are only blind to the treatment assignment. 30 minutes after the injection, a post-photograph will be used to evaluate NLF severity scale scores and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be collected from patients. The effectiveness analyses compare NLF severity scale scores and GAIS based on photograph records from physicians, as well as participant questionnaires for each group on every visit. The safety assessment evaluates any recorded adverse events following the device treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Normal saline
Participants will be randomly assigned to nasolabial or nasolabial\&cheekbone group and receive control treatment (20mg/ml hyaluronic acid mixed with 0.175 ml normal saline) in one side of the face.
Normal Saline
Lidocaine
Participants will be randomly assigned to nasolabial or nasolabial\&cheekbone group and receive experiment treatment (20mg/ml hyaluronic acid mixed with 0.175 ml 2% lidocaine) in one side of the face.
Lidocaine
Xylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia
Interventions
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Lidocaine
Xylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia
Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have ability to understand and comply with the study requirements
* Have approximately symmetrical nasolabial folds with a nasolabial folds severity score of 2-3 and the score difference between two sides is less 1
* Agree to refrain from undergoing other anti-wrinkle treatments in the injective areas 12 months after the injections.
* If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
* Be willing to provide written informed consent prior to any procedures
Exclusion Criteria
* Have history of coagulation defect diseases and still take aspirin, other anti-clotting, or blood activating medications 1 week before the treatments
* Had permanent or semi-permanent implantation on nasolabial areas
* Had dermal-related surgeries history (for example, laser, chemical dermabrasion, fraxel laser, thermocool) 6 months before the treatments.
* Had facial wrinkles and folds corrections (for example, botox or other dermal fillers) 6 months before the study starts
* Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
* Have a known history of allergic reactions to lidocaine other local anesthesia
* Have poor compliance with the study or follow-up schedule
30 Years
60 Years
ALL
Yes
Sponsors
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SciVision Biotech Inc.
INDUSTRY
Responsible Party
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Locations
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Department of Dermatology, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Beer K, Beer J. Overview of facial aging. Facial Plast Surg. 2009 Dec;25(5):281-4. doi: 10.1055/s-0029-1243075. Epub 2009 Dec 18.
Sveikata K, Balciuniene I, Tutkuviene J. Factors influencing face aging. Literature review. Stomatologija. 2011;13(4):113-6.
Albert AM, Ricanek K Jr, Patterson E. A review of the literature on the aging adult skull and face: implications for forensic science research and applications. Forensic Sci Int. 2007 Oct 2;172(1):1-9. doi: 10.1016/j.forsciint.2007.03.015. Epub 2007 Apr 16.
Mendelson B, Wong CH. Changes in the facial skeleton with aging: implications and clinical applications in facial rejuvenation. Aesthetic Plast Surg. 2012 Aug;36(4):753-60. doi: 10.1007/s00266-012-9904-3. Epub 2012 May 12.
Romagnoli M, Belmontesi M. Hyaluronic acid-based fillers: theory and practice. Clin Dermatol. 2008 Mar-Apr;26(2):123-59. doi: 10.1016/j.clindermatol.2007.09.001.
van Eijk T, Braun M. A novel method to inject hyaluronic acid: the Fern Pattern Technique. J Drugs Dermatol. 2007 Aug;6(8):805-8.
Colatsky TJ. Mechanisms of action of lidocaine and quinidine on action potential duration in rabbit cardiac Purkinje fibers. An effect on steady state sodium currents? Circ Res. 1982 Jan;50(1):17-27. doi: 10.1161/01.res.50.1.17. No abstract available.
Smith L, Cockerham K. Hyaluronic acid dermal fillers: can adjunctive lidocaine improve patient satisfaction without decreasing efficacy or duration? Patient Prefer Adherence. 2011 Mar 14;5:133-9. doi: 10.2147/PPA.S11251.
Related Links
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National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
Department of Dermatology, National Taiwan University Hospital
Taiwan Food and Drug Administration, Ministry of Health and Welfare
Other Identifiers
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RDCT-TAE
Identifier Type: -
Identifier Source: org_study_id
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