Clinical trial NCT02128204: The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
Official title: The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Nosalabial Folds Correction
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital Institutional Review Board. The aim of this post-marketing study is to evaluate the safety and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.

The study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be obtained before volunteers enter screening period. If the volunteers meet all the criteria, they will be given a number to replace their name in the study. The participants will be randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.


Eligibility criteria: Inclusion Criteria:

* Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
* Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
* Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
* Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 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
* Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures

Exclusion Criteria:

* Have history or active dermal diseases, inflammation, or any related disease
* Had permanent or semi-permanent implantation on nasolabial areas
* Had invasive aesthetic treatments or surgeries history 6 months before the treatments
* Had physical or chemical aesthetic treatments 1 months before the study starts
* Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
* Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
* Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
* Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
* Have poor compliance with the study or follow-up schedule

Primary outcomes:
measure: Adverse events report
timeFrame: From the date of treatment to 14 days
measure: Pain Visual Analog Scale
timeFrame: participants will be followed for the duration of treatment, an expected average of 10 minutes
Secondary outcomes:
measure: Nasolabial folds severity scale
timeFrame: From the baseline, 30 minutes post-treatment, and every follow-up at 1 and 2 weeks
measure: Global aesthetic improvement scale
timeFrame: 30 minutes post-treatments and follow-ups at 1 and 2 weeks
measure: Pain Visual Analog Scale
timeFrame: 15, 30, 45, and 60 minutes post-treatment
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Aesthetic Center of Yuan's General Hospital
Study officials:
affiliation: Department of Dermatology, Yuan's General Hospital
name: Chao-Hong Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: