PainNCT02128204
The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
A study testing lidocaine contained hyaluronate facial dermal filler and hyaluronate facial dermal filler in people with Pain and Nosalabial Folds Correction, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Nosalabial Folds Correction
- What is being tested?
- lidocaine contained hyaluronate facial dermal filler and hyaluronate facial dermal filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Nosalabial Folds Correction
- Being tested
- lidocaine contained hyaluronate facial dermal filler, hyaluronate facial dermal filler
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine contained hyaluronate facial dermal fillerDevice
Also called HYADERMIS LA Facial Dermal Implant
HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.
hyaluronate facial dermal fillerDevice
Also called Hya-Dermis Facial Dermal Implant
Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.
| Study group | Role | What they receive |
|---|---|---|
| HYADERMIS LA Facial Dermal Implant | Experimental | Subjects will be randomly assigned to receive experiment treatment, lidocaine contained hyaluronate facial dermal filler, in one side of the face. Receives: Device: lidocaine contained hyaluronate facial dermal filler |
| Hya-Dermis Facial Dermal Implant | Active comparator | Subjects will be randomly assigned to receive control treatment, hyaluronate facial dermal filler, in one side of the face. Receives: Device: hyaluronate facial dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events report
Any adverse events and abnormal physical parameters or reports occurred and disappeared should be monitored throughout the trial. The records should be assessed and keep on track of the severity of individual adverse events and correlation with the treatment. Severity assessment: To assess the level of severity by rating 0 (none), 1 (mild), 2 (median), and 3 (sever). Correlation assessment: Physicians evaluate the impact of adverse events for each individual and determine their causality of the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated ). Subjects will be given a medical diary after the treatment to record any adverse event and report to a physicians. Physicians keep following up adverse events until the symptoms stabilised.
Measured: From the date of treatment to 14 days
Pain Visual Analog Scale
A quantification of the severity of pain experienced by the participants during the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas during the treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.
Measured: participants will be followed for the duration of treatment, an expected average of 10 minutes
Secondary outcomes (3)
Nasolabial folds severity scale
Based on Skin Aging Altas: Volume 2, Asian type photographs, taking gender and nasolabial folds into consideration to quantify the degree of nosalabial folds severity. A validated 8-point photographic scale scored the severity grade from 0 (absent) 7 (extreme) will be used to assess the severity.
Measured: From the baseline, 30 minutes post-treatment, and every follow-up at 1 and 2 weeks
Global aesthetic improvement scale
To quantify the level of overall aesthetic improvement and so giving a scale from 1 (worse), 2 (no change), 3 (improved), and 4 (much improved), and 5 (very much improved).
Measured: 30 minutes post-treatments and follow-ups at 1 and 2 weeks
Pain Visual Analog Scale
A quantification of the severity of pain experienced by the participants after the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas at 15, 30, 45, and 60 minutes post-treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.
Measured: 15, 30, 45, and 60 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chao-Hong Liu, M.D., Principal investigator, Department of Dermatology, Yuan's General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128204
- Sponsor's protocol ID
- RDCT-YDL
- Status last verified
- Jan 2015
- First submitted
- 2 Apr 2014
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
- ClinicalTrials.gov ID
- NCT02128204
- Acronym / sponsor ID
- RDCT-YDL
- Conditions
- Pain, Nosalabial Folds Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYADERMIS LA Facial Dermal Implant | Experimental | Device: lidocaine contained hyaluronate facial dermal fillerSubjects will be randomly assigned to receive experiment treatment, lidocaine contained hyaluronate facial dermal filler, in one side of the face. |
| Hya-Dermis Facial Dermal Implant | Active comparator | Device: hyaluronate facial dermal fillerSubjects will be randomly assigned to receive control treatment, hyaluronate facial dermal filler, in one side of the face. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine contained hyaluronate facial dermal fillerAlso: HYADERMIS LA Facial Dermal ImplantHYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine. | Device | HYADERMIS LA Facial Dermal Implant |
| hyaluronate facial dermal fillerAlso: Hya-Dermis Facial Dermal ImplantHya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate. | Device | Hya-Dermis Facial Dermal Implant |
Primary outcome
Adverse events report
Time frame: From the date of treatment to 14 days
Any adverse events and abnormal physical parameters or reports occurred and disappeared should be monitored throughout the trial. The records should be assessed and keep on track of the severity of individual adverse events and correlation with the treatment. Severity assessment: To assess the level of severity by rating 0 (none), 1 (mild), 2 (median), and 3 (sever). Correlation assessment: Physicians evaluate the impact of adverse events for each individual and determine their causality of the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated ). Subjects will be given a medical diary after the treatment to record any adverse event and report to a physicians. Physicians keep following up adverse events until the symptoms stabilised.
Pain Visual Analog Scale
Time frame: participants will be followed for the duration of treatment, an expected average of 10 minutes
A quantification of the severity of pain experienced by the participants during the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas during the treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.
3 secondary outcomes
Nasolabial folds severity scale
Time frame: From the baseline, 30 minutes post-treatment, and every follow-up at 1 and 2 weeks
Global aesthetic improvement scale
Time frame: 30 minutes post-treatments and follow-ups at 1 and 2 weeks
Pain Visual Analog Scale
Time frame: 15, 30, 45, and 60 minutes post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Hong Liu, M.D. principal investigator
Department of Dermatology, Yuan's General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine contained hyaluronate facial dermal filler and hyaluronate facial dermal filler in people with Pain and Nosalabial Folds Correction, run by SciVision Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events report (time frame: From the date of treatment to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.