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Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction

Information source: SciVision Biotech Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasolabial Folds Correction; Pain

Intervention: Lidocaine (Drug); Normal Saline (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: SciVision Biotech Inc.

Overall contact:
Tsen-Fang Tsai, Doctor, Phone: 886-2-2356-2141, Email: tftsai@yahoo.com

Summary

This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed, single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan University Hospital Research Ethics Committee. The aim of this post-marketing study is to evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential loss to follow-up, the minimum enrollment was statistically determined to be 40 patients. 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.

Clinical Details

Official title: Safety and Efficacy Study of Hya-Dermis Mixed With Lidocaine Injection for the Improvement of Nasolabial Folds

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Pain Visual Analog Scale

Adverse events report

Secondary outcome:

Nasolabial folds (NLF) severity scale

Global aesthetic improvement scale (GAIS)

Aesthetic satisfaction questionnaire

Eligibility

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be 30 to 60 years of age and of any sex and willing to receive nasolabial folds

correction by intradermal injection procedures

- 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 or active dermal diseases, inflammation, or any related disease, such as

infection, psoriasis, and herpes.

- 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

Locations and Contacts

Tsen-Fang Tsai, Doctor, Phone: 886-2-2356-2141, Email: tftsai@yahoo.com

Department of Dermatology, National Taiwan University Hospital, Taipei 10048, Taiwan; Not yet recruiting
Tsen-Fang Tsai, Doctor, Phone: 886-2-2356-2141, Email: tftsai@yahoo.com
Tsen-Fang Tsai, Doctor, Principal Investigator
Additional Information

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

Related publications:

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. Review.

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. Epub 2007 Apr 16. Review.

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. Review.

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.

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.

Starting date: December 2015
Last updated: May 18, 2015

Page last updated: August 23, 2015

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