Nasolabial FoldNCT03844529
Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds
A study testing Sunmax FULLSGEN with Lidocaine in people with Nasolabial Fold, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- Sunmax FULLSGEN with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 31 Aug 2020
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral defects in the nasolabial folds with grades 3 or 4 on the Wrinkle Severity Rating Scale (WSRS).
- Male or female aged 20 ~ 65-year-old.
- Willingness to receive wrinkle augment treatment.
- Willingness to avoid other facial beauty therapy during this clinical trial.
- Healthy facial skin condition, and not have any disorder that can interfere the assessment of skin aging, e.g. facial nerve disorders.
- All the enrolled subjects should sign and date the informed consent form before this trial starts.
Who cannot join
- Known history of anaphylactoid reaction and other auto-immune diseases.
- Known history of allergies to collagen, or those who are allergic to the control or investigational device after the verification of intradermal allergy test.
- Known history of allergies to lidocaine.
- Known coagulation disorders.
- Females who have positive pregnancy test at screening, plan a pregnancy, breastfeeding, and those who are unable to take contraception method.
- Subjects with local infection, severity skin disease, inflammation or related symptoms on the nasolabial folds. Or with keloid (hypertrophic scar).
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- Subjects with severe cardiac, renal, hepatic, or respiratory diseases.
- Subjects with clinically diagnosed mental illness.
- According to American National Institute of Health standards, those who meet the criteria of Alcohol Use Disorder.
- Subjects take immunosuppressive drugs, chemotherapy, or systemic steroids (i.e. oral or injection) within 12 weeks before screening.
- Subjects take anticoagulant treatment or NSAIDs within 1 week before screening.
- Subjects have permanent implants in the nasolabial folds area.
- Subjects have nasolabial folds augment treatment such as autologous fat, hyaluronic acid or collagen filler implant within 52 weeks before screening.
- Subjects have nasolabial fold correctional procedure or treatment such as botulinum toxin injection, chemical peeling, laser at dermis or plastic surgery.
- Subjects unable to comply the scheduled follow-up.
- Subjects participate other clinical trials within 12 weeks before screening (trials only with questionnaire or specimen collection are exemption).
- Subjects who are not eligible for this trial based on the judgment of investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds: a Prospective, Randomized, Active-controlled, Double Blinded, Multicenter Clinical Trial
Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.
Read the detailed description
This is a prospective, randomized, active-controlled, double blinded (blinded evaluator and subject), multicenter clinical trial, which will be performed in Tri-Service General Hospital, Linkou ChangGung Memorial Hospital and National Taiwan University Hospital. These hospitals will recruit subjects in a competitive way. 240 subjects will be recruited in total, and each hospital will recruit 60~120 subjects. The expected execution period is 2018/10~2021/06. Subjects will be randomly assigned to receive the investigational device "Sumax FULLSGEN with Lidocaine" or controlled device "Sumax FACIALGAIN collagen Implant with Lidocaine" in 1:1 ratio. These devices will be processed to keep subjects and evaluators blinded.
- Conditions
- Nasolabial Fold
- Being tested
- Sunmax FULLSGEN with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunmax FULLSGEN with LidocaineDevice
Also called Sumax FACIALGAIN collagen Implant with Lidocaine
Subject who voluntarily sign the informed consent form (day -14~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Sunmax FULLSGEN with Lidocaine | Experimental | A subject would only receive single injection treatment(day 1) using Sunmax FULLSGEN , and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment. Receives: Device: Sunmax FULLSGEN with Lidocaine |
| Sumax FACIALGAIN collagen Implant with Lidocaine | Active comparator | A subject would only receive single injection treatment(day 1) using Sumax FACIALGAIN collagen Implant with Lidocaine, and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment. Receives: Device: Sunmax FULLSGEN with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS score evaluation
24th week response rate will be calculated according to WSRS score assessed by the evaluators Subtract the subject's WSRS baseline score from the Xth week after injection as improved score.
Measured: 24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
Secondary outcomes (5)
WSRS score evaluation within 4 time point as assessed by the evaluators
WSRS response rate at 4th, 12th, 36th and 52nd week as assessed by the evaluators
Measured: 4th, 12th, 36th and 52nd week week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
GAIS score at specific week as assessed by the subject
GAIS score at 4th, 12th, 24th, 36th and 52nd week as assessed by the subject
Measured: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
GAIS score at specific week as assessed by the evaluators
GAIS score at 4th, 12th, 24th, 36th and 52nd week as assessed by the evaluators
Measured: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
VAS score evaluation
VAS score within 30 mins after injection as assessed by the subject
Measured: 30 minutes. Double-sided print or photocopy the next 2 diagrams ensuring that the lines are exactly 10 cm in length and superimposed.
TPS score evaluation
TPS score within 30 mins after injection as assessed by the investigator
Measured: 30 minutes. The score is evaluated by thermometer pain scale, and the scale is 0-10. 0 stands for on pain, and 10 stands for worst possible pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Mar 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 240 subjects will be recruited in total, and each hospital will recruit 60\~120 subjects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Chang Gung Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844529
- Sponsor's protocol ID
- 201809007DSA
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds: a Prospective, Randomized, Active-controlled, Double Blinded, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03844529
- Acronym / sponsor ID
- 201809007DSA
- Conditions
- Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Chang Gung Memorial Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 18 Feb 2019 (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.
Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.
Detailed description
This is a prospective, randomized, active-controlled, double blinded (blinded evaluator and subject), multicenter clinical trial, which will be performed in Tri-Service General Hospital, Linkou ChangGung Memorial Hospital and National Taiwan University Hospital. These hospitals will recruit subjects in a competitive way. 240 subjects will be recruited in total, and each hospital will recruit 60~120 subjects. The expected execution period is 2018/10~2021/06. Subjects will be randomly assigned to receive the investigational device "Sumax FULLSGEN with Lidocaine" or controlled device "Sumax FACIALGAIN collagen Implant with Lidocaine" in 1:1 ratio. These devices will be processed to keep subjects and evaluators blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 240 subjects will be recruited in total, and each hospital will recruit 60~120 subjects.
| Arm | Type | Receives |
|---|---|---|
| Sunmax FULLSGEN with Lidocaine | Experimental | Device: Sunmax FULLSGEN with LidocaineA subject would only receive single injection treatment(day 1) using Sunmax FULLSGEN , and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment. |
| Sumax FACIALGAIN collagen Implant with Lidocaine | Active comparator | Device: Sunmax FULLSGEN with LidocaineA subject would only receive single injection treatment(day 1) using Sumax FACIALGAIN collagen Implant with Lidocaine, and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bilateral defects in the nasolabial folds with grades 3 or 4 on the Wrinkle Severity Rating Scale (WSRS).
- Male or female aged 20 ~ 65-year-old.
- Willingness to receive wrinkle augment treatment.
- Willingness to avoid other facial beauty therapy during this clinical trial.
- Healthy facial skin condition, and not have any disorder that can interfere the assessment of skin aging, e.g. facial nerve disorders.
Key exclusion criteria (17 listed)
- Known history of anaphylactoid reaction and other auto-immune diseases.
- Known history of allergies to collagen, or those who are allergic to the control or investigational device after the verification of intradermal allergy test.
- Known history of allergies to lidocaine.
- Known coagulation disorders.
- Females who have positive pregnancy test at screening, plan a pregnancy, breastfeeding, and those who are unable to take contraception method.
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 |
|---|---|---|
| Sunmax FULLSGEN with LidocaineAlso: Sumax FACIALGAIN collagen Implant with LidocaineSubject who voluntarily sign the informed consent form (day -14~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits. | Device | Sumax FACIALGAIN collagen Implant with Lidocaine, Sunmax FULLSGEN with Lidocaine |
Primary outcome
WSRS score evaluation
Time frame: 24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
24th week response rate will be calculated according to WSRS score assessed by the evaluators Subtract the subject's WSRS baseline score from the Xth week after injection as improved score.
5 secondary outcomes
WSRS score evaluation within 4 time point as assessed by the evaluators
Time frame: 4th, 12th, 36th and 52nd week week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
GAIS score at specific week as assessed by the subject
Time frame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
GAIS score at specific week as assessed by the evaluators
Time frame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
VAS score evaluation
Time frame: 30 minutes. Double-sided print or photocopy the next 2 diagrams ensuring that the lines are exactly 10 cm in length and superimposed.
TPS score evaluation
Time frame: 30 minutes. The score is evaluated by thermometer pain scale, and the scale is 0-10. 0 stands for on pain, and 10 stands for worst possible pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Individual participant dataSharing planned: No
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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 Sunmax FULLSGEN with Lidocaine in people with Nasolabial Fold, run by National Taiwan University Hospital 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 17 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. 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?
Results are not available in the source record.
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 score evaluation (time frame: 24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.). 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 18 Mar 2019.