WithdrawnNot Applicable

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

Taiwan0

Plain-language 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.

Who can participate

Age range

30 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Visual Analog Scale

Timeframe: 30 miuntes post-treatment

Adverse events report

Timeframe: From date of treatment to 12 months

Trial details

NCT IDNCT02006173

SponsorSciVision Biotech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Nasolabial Folds Correction trials