Nasolabial Folds CorrectionNCT02006173
Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction
A study testing Lidocaine and Normal Saline in people with Nasolabial Folds Correction and Pain, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds Correction, Pain
- What is being tested?
- Lidocaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Start not givento Jul 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dermatology, National Taiwan University Hospital
Taipei, 10048
About this study
Official title: Safety and Efficacy Study of Hya-Dermis Mixed With Lidocaine Injection for the Improvement of Nasolabial Folds
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.
- Conditions
- Nasolabial Folds Correction, Pain
- Being tested
- Lidocaine, Normal Saline
- Keywords
- Hya-Dermis mixed with lidocaine on reducing pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
Xylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | 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. Receives: Drug: Normal Saline |
| Lidocaine | Active comparator | 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale
A quantification of the severity of pain experienced by individuals during the treatments. A scale of 100 mm horizontal line will be labeled by participants to assess pain on both sides of the injected areas 30 minutes after the treatment. The one on the extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by participants.
Measured: 30 miuntes post-treatment
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. Based on the correlation with the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated).
Adverse events tracking:
Any adverse events should be reported to the physicians by participants. Physicians keep following up adverse events experienced participants until the event disappeared or the symptoms stabilized.
Measured: From date of treatment to 12 months
Secondary outcomes (3)
Nasolabial folds (NLF) severity scale
Based on Skin Aging Atlas: Volume 2, Asian type photographs13, taking gender and NLF into consideration to quantify the degree of NLF severity. A validated 8-point photographic scale scored the severity grade from 0 (absent) to 7 (extreme) will be used to assess the severity of NLF at baseline, 30 minutes post-treatment, and every follow-up at 1, 3, 6, 9, 12 months.
Measured: From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months
Global aesthetic improvement scale (GAIS)
To quantify the level of overall aesthetic improvement 30 minutes after treatments and every follow-up at 1, 3, 6, 9, 12 months. A scale from 1 to 5 represent worse (1), no change (2), improved (3), much improved (4), and very much improved (5).
Measured: 30 minutes post-treatments and follow-ups at 1, 3, 6, 9, 12 months
Aesthetic satisfaction questionnaire
Subjects subjectively assessed overall satisfaction of general appearance toward the effectiveness of the treatment by rating 1 (not at all satisfied), 2 (not satisfied), 3 (neither satisfied nor dissatisfied), 4 (somewhat satisfied), and 5 (highly satisfied).
Measured: From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nasolabial Folds CorrectionStudies 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, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006173
- Sponsor's protocol ID
- RDCT-TAE
- Status last verified
- Apr 2016
- First submitted
- 4 Dec 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20024868Sveikata K, Balciuniene I, Tutkuviene J. Factors influencing face aging. Literature review. Stomatologija. 2011;13(4):113-6.
PubMed 22362337Albert 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.
PubMed 17434276Mendelson 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.
PubMed 22580543Romagnoli 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.
PubMed 18472056van Eijk T, Braun M. A novel method to inject hyaluronic acid: the Fern Pattern Technique. J Drugs Dermatol. 2007 Aug;6(8):805-8.
PubMed 17763611Colatsky 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.
PubMed 6274542Smith 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.
PubMed 21448297
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Hya-Dermis Mixed With Lidocaine Injection for the Improvement of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02006173
- Acronym / sponsor ID
- RDCT-TAE
- Conditions
- Nasolabial Folds Correction, Pain
- Keywords
- Hya-Dermis mixed with lidocaine on reducing pain
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Primary completion
- Jul 2015 (actual)
- First posted
- 10 Dec 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal SalineParticipants 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. |
| Lidocaine | Active comparator | Drug: LidocaineParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| LidocaineAlso: XylocaineXylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia | Drug | Lidocaine |
| Normal Saline | Drug | Normal saline |
Primary outcome
Pain Visual Analog Scale
Time frame: 30 miuntes post-treatment
A quantification of the severity of pain experienced by individuals during the treatments. A scale of 100 mm horizontal line will be labeled by participants to assess pain on both sides of the injected areas 30 minutes after the treatment. The one on the extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by participants.
Adverse events report
Time frame: From date of treatment to 12 months
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. Based on the correlation with the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated). Adverse events tracking: Any adverse events should be reported to the physicians by participants. Physicians keep following up adverse events experienced participants until the event disappeared or the symptoms stabilized.
3 secondary outcomes
Nasolabial folds (NLF) severity scale
Time frame: From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months
Global aesthetic improvement scale (GAIS)
Time frame: 30 minutes post-treatments and follow-ups at 1, 3, 6, 9, 12 months
Aesthetic satisfaction questionnaire
Time frame: From the baseline, 30 minutes post-treatment, to every follow-up at 1, 3, 6, 9, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Background: PubMed 20024868Beer 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.
- Background: PubMed 22362337Sveikata K, Balciuniene I, Tutkuviene J. Factors influencing face aging. Literature review. Stomatologija. 2011;13(4):113-6.
- Background: PubMed 17434276Albert 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.
- Background: PubMed 22580543Mendelson 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.
- Background: PubMed 18472056Romagnoli 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.
- Background: PubMed 17763611van Eijk T, Braun M. A novel method to inject hyaluronic acid: the Fern Pattern Technique. J Drugs Dermatol. 2007 Aug;6(8):805-8.
- Background: PubMed 6274542Colatsky 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.
- Background: PubMed 21448297Smith 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.
- National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)Link provided by the sponsor.
- Department of Dermatology, National Taiwan University HospitalLink provided by the sponsor.
- Taiwan Food and Drug Administration, Ministry of Health and WelfareLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Normal Saline in people with Nasolabial Folds Correction and Pain, 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 8 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: withdrawn, as of the sponsor's last update on 29 Apr 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain Visual Analog Scale (time frame: 30 miuntes post-treatment). 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?
On the ClinicalTrials.gov record for NCT02006173, which also lists 8 linked publications.
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 29 Apr 2016.