Dermal FillerNCT04569045
Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds
A study testing HA+Lidocaine and HA in people with Dermal Filler and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in China.
Trial summary
The aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler, Hyaluronic Acid, Lidocaine
- What is being tested?
- HA+Lidocaine and HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2020to 10 Dec 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years of male or female
- Wrinkle Severity Rating Scale (WSRS) of bilateral nasolabial folds graded 3 or 4 by blinded evaluator (moderate to severe bilateral nasolabial fold), consistent grade of bilateral nasolabial folds, and the grades approved by the physician who perform the treatment
- Agree not to undergo any other under-eye facial surgery (including nose) during the study period
Who cannot join
- Injection site with infection or other skin diseases present which may affect the evaluation
- With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at nasolabial folds
- With permanent implants or planning to receive permanent implants during the study period at the injection sites
- Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 12 months
- With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
- With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
Show all 21Show fewer
- With prescription medication for nasolabial fold treatment, topical corticosteroid, skinirritating topical products or pigmentation products within the past 2 weeks or planning to take these medication or products during the study period
- With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.)
- Severe liver or kidney defects (such as the value of ALT or AST over 1.5 folds of upper limit of normal value; the value of creatinine over 1.5 folds of upper limit of normal value)
- With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis removement medications
- With epilepsy or porphyria
- With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
- With the need to take b-blocker during the study period
- With severe atrioventricular block (type 2 second-degree AV block and third-degree AV block)
- With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
- With orthodontics, tooth extraction, tooth implantation (extraction or implantation of tooth anterior to the second premolar) or planning to receive these procedures during the study
- With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study
- Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change
- Pregnant, planning pregnancy or in breastfeeding females
- With syphilis or HIV infection
- Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Within-subject Controlled Clinical Study to Evaluate the Safety and Effectiveness of Pain Relief of Modified Sodium Hyaluronate Gel for Injection When Used for the Correction of Moderate or Severe Nasolabial Folds
The aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds.
Read the detailed description
One hundred and thirty patients were enrolled and there two sides of nasolabial folds (NLF) were randomized to receive HA with lidocaine or HA. The primary outcome was immediate visual analogue scale (VAS) of pain evaluated after injection for both NLF sides. Secondary outcomes including VAS pain, wrinkle severity rating scale (WSRS), global aesthetic improvement scale (GAIS) and AE were observed at 1, 3, 6, 9, 12 follow-ups.
- Conditions
- Dermal Filler, Hyaluronic Acid, Lidocaine, Nasolabial Fold
- Being tested
- HA+Lidocaine, HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA+LidocaineDevice
20 mg
HADevice
20 mg
| Study group | Role | What they receive |
|---|---|---|
| HA + Lidocaine | Experimental | Sodium Hyaluronate with Lidocaine Hydrochloride Receives: Device: HA+Lidocaine |
| HA | Active comparator | Sodium Hyaluronate Receives: Device: HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate VAS pain evaluated after injection for both NLF sides
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Measured: Immediate post-injection
Secondary outcomes (4)
VAS pain evaluated 15, 30, 45 and 60 minutes after injection for both NLF sides
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Measured: 15, 30, 45 and 60 minutes post-injection
On-site WSRS evaluated by site blinded-evaluator at 1, 3, 6, 9 and 12 months
Evaluators assess the wrinkle severity of nasolabial folds on site or photographically with 5 graded scale,1 to 5 was represented 'absent' to 'extreme'.
Measured: 1, 3, 6, 9 and 12 months post-injection
GAIS evaluated photographically by independent blinded-evaluator at 1, 3, 6, 9 and 12 months
Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.
Measured: 1, 3, 6, 9 and 12 months post-injection
Adverse events reported from the baseline and during the study period
The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.
Measured: 1, 3, 6, 9 and 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start20 Aug 2020
- Primary completion4 Dec 2020
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal FillerStudies 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
- Model description
- Subject's two sides of nasolabial folds (NLF) were randomized to receive FACILLE® Light (contains Lidocaine) or FACILLE® (without Lidocaine).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 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
- NCT04569045
- Sponsor's protocol ID
- RDCT-CNFL
- Status last verified
- Feb 2021
- First submitted
- 23 Sep 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Within-subject Controlled Clinical Study to Evaluate the Safety and Effectiveness of Pain Relief of Modified Sodium Hyaluronate Gel for Injection When Used for the Correction of Moderate or Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04569045
- Acronym / sponsor ID
- RDCT-CNFL
- Conditions
- Dermal Filler, Hyaluronic Acid, Lidocaine, Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 29 Sep 2020 (actual)
- 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 aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds.
Detailed description
One hundred and thirty patients were enrolled and there two sides of nasolabial folds (NLF) were randomized to receive HA with lidocaine or HA. The primary outcome was immediate visual analogue scale (VAS) of pain evaluated after injection for both NLF sides. Secondary outcomes including VAS pain, wrinkle severity rating scale (WSRS), global aesthetic improvement scale (GAIS) and AE were observed at 1, 3, 6, 9, 12 follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subject's two sides of nasolabial folds (NLF) were randomized to receive FACILLE® Light (contains Lidocaine) or FACILLE® (without Lidocaine).
| Arm | Type | Receives |
|---|---|---|
| HA + Lidocaine | Experimental | Device: HA+LidocaineSodium Hyaluronate with Lidocaine Hydrochloride |
| HA | Active comparator | Device: HASodium Hyaluronate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years of male or female
- Wrinkle Severity Rating Scale (WSRS) of bilateral nasolabial folds graded 3 or 4 by blinded evaluator (moderate to severe bilateral nasolabial fold), consistent grade of bilateral nasolabial folds, and the grades approved by the physician who perform the treatment
- Agree not to undergo any other under-eye facial surgery (including nose) during the study period
Key exclusion criteria (21 listed)
- Injection site with infection or other skin diseases present which may affect the evaluation
- With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at nasolabial folds
- With permanent implants or planning to receive permanent implants during the study period at the injection sites
- Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 12 months
- With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
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 |
|---|---|---|
| HA+Lidocaine20 mg | Device | HA + Lidocaine |
| HA20 mg | Device | HA |
Primary outcome
Immediate VAS pain evaluated after injection for both NLF sides
Time frame: Immediate post-injection
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
4 secondary outcomes
VAS pain evaluated 15, 30, 45 and 60 minutes after injection for both NLF sides
Time frame: 15, 30, 45 and 60 minutes post-injection
On-site WSRS evaluated by site blinded-evaluator at 1, 3, 6, 9 and 12 months
Time frame: 1, 3, 6, 9 and 12 months post-injection
GAIS evaluated photographically by independent blinded-evaluator at 1, 3, 6, 9 and 12 months
Time frame: 1, 3, 6, 9 and 12 months post-injection
Adverse events reported from the baseline and during the study period
Time frame: 1, 3, 6, 9 and 12 months post-injection
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 25 Feb 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA+Lidocaine and HA in people with Dermal Filler and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in China.
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 3 inclusion and 21 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Immediate VAS pain evaluated after injection for both NLF sides (time frame: Immediate post-injection). 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 25 Feb 2022.