Dermal FillerNCT05822778
Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
A study testing Formaderm Dermal Filler Injection and "Q-MED" RESTYLANE in people with Dermal Filler, run by Maxigen Biotech Inc..
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are: The differences of Wrinkle Severity Rating Scale (WSRS) after the injection. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler
- What is being tested?
- Formaderm Dermal Filler Injection and "Q-MED" RESTYLANE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2014to 30 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are aged 30-65 years old of both sexes.
- Subjects who are willing to undergo WSRS therapy.
- The WSRS baseline measurement should be 3-4 points and the left and right side should be in symmetry.
- The facial skin is healthy, without any disease that possibly interferes with skin aging status assessment.
- The subject is willing to avoid undergoing other cosmetic treatment and surgery, including Botox injection.
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 severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and the like.
- Those who have undergone cosmetic treatment or surgery prior to the trial:
- Those who have undergone laser treatment or dermabrasion within the past 12 months.
- Those who have undergone chemical peels treatment within the last three months.
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- Those who have undergone facial wrinkle augmentation surgery such as Botox injections within the past 12 months.
- Those with silicone in their body or material that cannot be absorbed by the body (permanent filling agent).
- Those who have undergone facial surgery or filing agent implants in the nasolabial fold area within the past 24 months.
- Those who have a scar or localized infection in the nasolabial fold area.
- Those with connective tissue diseases.
- Those with diabetes or systemic disease that cannot be controlled.
- Those suffering from human immunodeficiency syndrome.
- Those suffering from immunity related disorder or have had immune system degradation in the past.
- Those with a scar-prone constitution, prone to scar formation or hypertrophic scars.
- Those who have joined other clinical trials such ass medical device related and other similar trials within the past six months.
- Those with a medical history of cosmetic filling agent allergy, any type of hyaluronic acid implants, or drugs (such as antibiotics, antihistamine, non-steroidal anti-inflammatory analgesics), or those with a medical history of local anesthetic allergy.
- Patients undergoing anticoagulant treatment, those who have a medical history of coagulation defects, or those taking Chinese medicine for promoting blood circulation.
- Those whose medication and medical conditions are deemed unfit for inclusion in the research based on the judgment of the researcher.
- Those who are unable to comply with re-visit schedule or are unwell to sign the informed consent.
About this study
Official title: Safety and Efficacy Study of Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are:
- The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
- The differences of Global Aesthetic Improvement Scale (GAIS) after the injection.
- The subjective satisfaction of treatment.
- Safety Indicators of which incidences on the day of the injection or after the injection.
Read more
Participants will be self-controlled and randomized for same period
- received both trial product and control product at the same time.
- re-visited on week 2, 4, 12, 24, 36, and 52 after injection.
Researchers will compare if the test product is non-inferiority to Q-Med Restylane.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior, randomized, double-blind trial with a control group was conducted in this study. Every subject received the trial product and control product injections at the same time. It was planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1：2003 Clinical investigation of medical devices for human subjects - Part 1: General Requirements and carried out according to the trial proposal approved by the Tri-Service General Hospital Human Subjects Review Committee.
- Conditions
- Dermal Filler
- Being tested
- Formaderm Dermal Filler Injection, "Q-MED" RESTYLANE
- Keywords
- hyaluronic acid filler, nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formaderm Dermal Filler InjectionDevice
Dermal filler injection to facial areas
"Q-MED" RESTYLANEDevice
Dermal filler injection to facial areas
| Study group | Role | What they receive |
|---|---|---|
| Formaderm(FD) group | Experimental | Formaderm was randomly administered either side of subjects' facial areas once. The injection volume was limited to 2c.c. Receives: Device: Formaderm Dermal Filler Injection |
| control group | Active comparator | As a self-controlled study, "Q-MED" RESTYLANE would be administered on the other side after injected Formaderm. The injection volume was limited to 2c.c. Receives: Device: "Q-MED" RESTYLANE |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS improvement ratio at week 24 post-injection
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. 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 week 24
Secondary outcomes (4)
Difference of WSRS score
Based on the photographs, 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) And the difference of WSRS score was calculated as week 2, 4, 12 and 24 subtracted from baseline.
Measured: Baseline to week 24 post-injection
GAIS score
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 respectively. And the difference of GAIS score was assessed at week 2, 4, 12 and 24.
Measured: Baseline to week 24 post-injection
Difference of Satisfaction of treatment
Subjects rated the points of satisfaction after treatment subjectively from 1(extremely dissatisfied) to 5(extremely satisfied). And the difference of satisfaction was calculated as week 2, 4, 12 and 24 subtracted from baseline.
Measured: Baseline to week 24 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: week 0 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start13 Feb 2014
- Primary completion15 Mar 2015
- Study completion30 Jun 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 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
- NCT05822778
- Sponsor's protocol ID
- 2-102-05-113
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 21 Apr 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
- ClinicalTrials.gov ID
- NCT05822778
- Acronym / sponsor ID
- 2-102-05-113
- Conditions
- Dermal Filler
- Keywords
- hyaluronic acid filler, nasolabial folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2014 (actual)
- Primary completion
- 15 Mar 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 21 Apr 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 (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are:
- The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
- The differences of Global Aesthetic Improvement Scale (GAIS) after the injection.
- The subjective satisfaction of treatment.
- Safety Indicators of which incidences on the day of the injection or after the injection.
Participants will be self-controlled and randomized for same period
- received both trial product and control product at the same time.
- re-visited on week 2, 4, 12, 24, 36, and 52 after injection.
Researchers will compare if the test product is non-inferiority to Q-Med Restylane.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior, randomized, double-blind trial with a control group was conducted in this study. Every subject received the trial product and control product injections at the same time. It was planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1：2003 Clinical investigation of medical devices for human subjects - Part 1: General Requirements and carried out according to the trial proposal approved by the Tri-Service General Hospital Human Subjects Review Committee.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formaderm(FD) group | Experimental | Device: Formaderm Dermal Filler InjectionFormaderm was randomly administered either side of subjects' facial areas once. The injection volume was limited to 2c.c. |
| control group | Active comparator | Device: "Q-MED" RESTYLANEAs a self-controlled study, "Q-MED" RESTYLANE would be administered on the other side after injected Formaderm. The injection volume was limited to 2c.c. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are aged 30-65 years old of both sexes.
- Subjects who are willing to undergo WSRS therapy.
- The WSRS baseline measurement should be 3-4 points and the left and right side should be in symmetry.
- The facial skin is healthy, without any disease that possibly interferes with skin aging status assessment.
- The subject is willing to avoid undergoing other cosmetic treatment and surgery, including Botox injection.
Key exclusion criteria (20 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 severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and the like.
- Those who have undergone cosmetic treatment or surgery prior to the trial:
- Those who have undergone laser treatment or dermabrasion within the past 12 months.
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 Dermal Filler InjectionDermal filler injection to facial areas | Device | Formaderm(FD) group |
| "Q-MED" RESTYLANEDermal filler injection to facial areas | Device | control group |
Primary outcome
WSRS improvement ratio at week 24 post-injection
Time frame: Baseline and week 24
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. 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.
4 secondary outcomes
Difference of WSRS score
Time frame: Baseline to week 24 post-injection
GAIS score
Time frame: Baseline to week 24 post-injection
Difference of Satisfaction of treatment
Time frame: Baseline to week 24 post-injection
Incidence of Treatment-related Adverse Events
Time frame: week 0 to week 52
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 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing Formaderm Dermal Filler Injection and "Q-MED" RESTYLANE in people with Dermal Filler, run by Maxigen Biotech Inc..
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 5 inclusion and 20 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 week 24 post-injection (time frame: Baseline and week 24). 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 Apr 2023.