Dermal FillerNCT04599335
The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face
A study testing 2% HA in people with Dermal Filler and Hyaluronic Acid, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial summary
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler, Hyaluronic Acid, Lidocaine
- What is being tested?
- 2% HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2021to 9 May 2023
- 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
- Age 30 to 60 years of male or female
- MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.
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 midface
- 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 6 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 Major surgery 3 months before the start of the trial
Show all 16Show fewer
- 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
- 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.)
- With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications
- With epilepsy or porphyria
- With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
- With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
- 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
- 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
1 site in 1 country.
About this study
Official title: The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.
- Conditions
- Dermal Filler, Hyaluronic Acid, Lidocaine, Aging Mid-Face
- Being tested
- 2% HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% HADevice
2% HA
| Study group | Role | What they receive |
|---|---|---|
| HA + Lidocaine | Experimental | Not described Receives: Device: 2% HA |
| Negative | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).
The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.
Measured: 6 months
Secondary outcomes (8)
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.
The digital image scoring system analyzes the volume change (ml).
Measured: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Evaluators assess the midface volume deficit scale on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.
Measured: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.
Measured: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.
Measured: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Measured: Immediate,15, 30, 45 and 60 minutes 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: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Serious 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: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Device failure 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: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start6 Apr 2021
- Primary completion4 Nov 2021
- Study completion9 May 2023
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT04599335
- Sponsor's protocol ID
- RDCT-AHSK1
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face
- ClinicalTrials.gov ID
- NCT04599335
- Acronym / sponsor ID
- RDCT-AHSK1
- Conditions
- Dermal Filler, Hyaluronic Acid, Lidocaine, Aging Mid-Face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 22 Oct 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.
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA + Lidocaine | Experimental | Device: 2% HA |
| Negative | No intervention | – |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30 to 60 years of male or female
- MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.
Key exclusion criteria (16 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 midface
- 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 6 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 |
|---|---|---|
| 2% HA2% HA | Device | HA + Lidocaine |
Primary outcome
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).
Time frame: 6 months
The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.
8 secondary outcomes
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.
Time frame: Immediate,15, 30, 45 and 60 minutes post-injection
Adverse events reported from the baseline and during the study period
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Serious adverse events reported from the baseline and during the study period
Time frame: Baseline, 1, 3, 6, 12, 18 and 24 months post-injection
Device failure reported from the baseline and during the study period
Time frame: Baseline
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 19 Oct 2023.
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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 2% HA in people with Dermal Filler and Hyaluronic Acid, 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 2 inclusion and 16 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 19 Oct 2023. 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?
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS). (time frame: 6 months). 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 19 Oct 2023.