Hyaluronic AcidNCT05935501
Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler
A study testing Formaderm Young and Restylane in people with Hyaluronic Acid and Dermal Fillers, run by Maxigen Biotech Inc. at 2 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyaluronic Acid, Dermal Fillers
- What is being tested?
- Formaderm Young and Restylane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- 27 Aug 2018to 6 Apr 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are aged 18-65 years old of both sexes.
- Subjects who are willing to undergo both sides nasolabial fold therapy.
- The baseline measurement on the wrinkle severity rating scale (WSRS) should be 3-4 points, and the left and right sides should exhibit symmetry.
- Willing to comply with re-visit schedule and sign the informed consent.
Who cannot join
- Women subjects who are pregnant, breastfeeding, planning to become pregnant, and not willing to take contraception during the trial period.
- Those who are emotionally unstable or suffering from a mental disease.
- Those who have unhealthy facial skin or severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and similar conditions.
- Those with any disease that would interfere the assessment of skin aging.
- Those who have a scar in the nasolabial fold area.
- Those with connective tissue diseases.
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- Those with diabetes or systemic disease that cannot be controlled.
- Those suffering from immunity related disorder.
- Those with a scar-prone constitution.
- Patients undergoing anticoagulant treatment, those who have a medical history of coagulation defects.
- Patients taking antiplatelet medicine that could affect platelet function, such as Aspirin or non-steroidal anti-inflammatory analgesics.
- Those with a allergy history of cosmetic filling agent, any type of hyaluronic acid implants or local anesthetic.
- Those who have undergone facial cosmetic treatments or surgery before the trial:
- Chemical or physical treatments that affect local configuration before the trial, such as laser procedures, skin resurfacing, chemical peel or Face Wrinkle Correction Surgery within 6 month.
- Facial surgery or dermal filler at nasolabial fold area within 12 month.
- Those who have cosmetic surgery with silicone in their body or material that cannot be absorbed by the body (permanent filling agent).
- Those who are not willing to avoid undergoing other cosmetic treatment and surgery, such as facial filling, botulinum toxin Injection, laser procedures, chemical peel or facelift surgery.
- Those who have participate in another clinical investigation within 12 month.
- Those who are deemed unfit for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Chaoyang, 100029
Beijing Tongren Hospital, Capital Medical University
Beijing, Tongren, 100005
About this study
Official title: Safety and Efficacy of Formaderm Young Dermal Filler Injection for the Correction of Moderate-to-severe Facial Wrinkles.
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles.
The main questions it aims to answer are:
Read more
- The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
- The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS).
- Safety Indicators of which incidences on the day of the injection or after the injection.
Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection.
Researchers will compare if the test product is non-inferiority to Restylane.
Read the detailed description
A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was conducted in this study. It was planned to recruit 157 subjects for each group, considering a 10% dropout rate that would lead to 320 subjects overall.
Subjects eligible in the screening will be enrolled. Each patient will receive the same treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides of the nasolabial fold through randomization.
Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be identified and recorded during the course of the study.
- Conditions
- Hyaluronic Acid, Dermal Fillers
- Being tested
- Formaderm Young, Restylane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formaderm YoungDevice
Dermal filler injection to facial areas.
RestylaneDevice
Dermal filler injection to facial areas.
| Study group | Role | What they receive |
|---|---|---|
| Formaderm Young | Experimental | Formaderm Young was randomly administered to subjects. The injection volume was limited to 2c.c. Receives: Device: Formaderm Young |
| Restylane | Active comparator | Restylane was randomly administered to subjects. The injection volume was limited to 2c.c. Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS improvement ratio at 6 month post-injection
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 6 month post-injection. A positive value indicated"effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
Measured: Baseline and 6 month post-injection
Secondary outcomes (5)
WSRS score
Blinded physician rated the score of WSRS(Wrinkle Severity Rating Scales) for both group respectively. The WSRS is a 5-grade instrument for facial wrinkle, Grade 1(absent, no visible nasolabial fold; continuous skin line ) to Grade 5(extreme, extremely deep and long nasolabial fold, detrimental to facial appearance;2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone).
Measured: Baseline and 1 month, 3month, 6month post-injection
WSRS improvement ratio
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 1 month and 3 month post-injection. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
Measured: Baseline, 1 month and 3month post-injection
GAIS score assessed by physician
Compared with the baseline photographs, blinded physician rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively.
Measured: Baseline, 1 month, 3month and 6month post-injection
GAIS score assessed by subjects
Compared with baseline, subjects themselves rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively.
Measured: Baseline, 1 month, 3month and 6month post-injection
Incidence of Treatment-related Adverse Events
The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.
Measured: Month 0 to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start27 Aug 2018
- Primary completion20 Oct 2021
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic AcidStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935501
- Sponsor's protocol ID
- MBI-2016-01
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 7 Jul 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 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Formaderm Young Dermal Filler Injection for the Correction of Moderate-to-severe Facial Wrinkles.
- ClinicalTrials.gov ID
- NCT05935501
- Acronym / sponsor ID
- MBI-2016-01
- Conditions
- Hyaluronic Acid, Dermal Fillers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 7 Jul 2023 (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 goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles.
The main questions it aims to answer are:
- The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
- The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS).
- Safety Indicators of which incidences on the day of the injection or after the injection.
Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection.
Researchers will compare if the test product is non-inferiority to Restylane.
Detailed description
A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was conducted in this study. It was planned to recruit 157 subjects for each group, considering a 10% dropout rate that would lead to 320 subjects overall.
Subjects eligible in the screening will be enrolled. Each patient will receive the same treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides of the nasolabial fold through randomization.
Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be identified and recorded during the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formaderm Young | Experimental | Device: Formaderm YoungFormaderm Young was randomly administered to subjects. The injection volume was limited to 2c.c. |
| Restylane | Active comparator | Device: RestylaneRestylane was randomly administered to subjects. The injection volume was limited to 2c.c. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are aged 18-65 years old of both sexes.
- Subjects who are willing to undergo both sides nasolabial fold therapy.
- The baseline measurement on the wrinkle severity rating scale (WSRS) should be 3-4 points, and the left and right sides should exhibit symmetry.
- Willing to comply with re-visit schedule and sign the informed consent.
Key exclusion criteria (19 listed)
- Women subjects who are pregnant, breastfeeding, planning to become pregnant, and not willing to take contraception during the trial period.
- Those who are emotionally unstable or suffering from a mental disease.
- Those who have unhealthy facial skin or severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and similar conditions.
- Those with any disease that would interfere the assessment of skin aging.
- Those who have a scar in the nasolabial fold area.
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 |
|---|---|---|
| Formaderm YoungDermal filler injection to facial areas. | Device | Formaderm Young |
| RestylaneDermal filler injection to facial areas. | Device | Restylane |
Primary outcome
WSRS improvement ratio at 6 month post-injection
Time frame: Baseline and 6 month post-injection
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 6 month post-injection. A positive value indicated"effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
5 secondary outcomes
WSRS score
Time frame: Baseline and 1 month, 3month, 6month post-injection
WSRS improvement ratio
Time frame: Baseline, 1 month and 3month post-injection
GAIS score assessed by physician
Time frame: Baseline, 1 month, 3month and 6month post-injection
GAIS score assessed by subjects
Time frame: Baseline, 1 month, 3month and 6month post-injection
Incidence of Treatment-related Adverse Events
Time frame: Month 0 to month 12
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 7 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formaderm Young and Restylane in people with Hyaluronic Acid and Dermal Fillers, run by Maxigen 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 4 inclusion and 19 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 7 Jul 2023. 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?
WSRS improvement ratio at 6 month post-injection (time frame: Baseline and 6 month 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 7 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.