Clinical trial NCT03844529: Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasolabial Fold
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
name: Chang Gung Memorial Hospital
First posted: 2019-02-18
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 240 subjects will be recruited in total, and each hospital will recruit 60\~120 subjects.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Bilateral defects in the nasolabial folds with grades 3 or 4 on the Wrinkle Severity Rating Scale (WSRS).
2. Male or female aged 20 \~ 65-year-old.
3. Willingness to receive wrinkle augment treatment.
4. Willingness to avoid other facial beauty therapy during this clinical trial.
5. Healthy facial skin condition, and not have any disorder that can interfere the assessment of skin aging, e.g. facial nerve disorders.
6. All the enrolled subjects should sign and date the informed consent form before this trial starts.

Exclusion Criteria:

1. Known history of anaphylactoid reaction and other auto-immune diseases.
2. Known history of allergies to collagen, or those who are allergic to the control or investigational device after the verification of intradermal allergy test.
3. Known history of allergies to lidocaine.
4. Known coagulation disorders.
5. Females who have positive pregnancy test at screening, plan a pregnancy, breastfeeding, and those who are unable to take contraception method.
6. Subjects with local infection, severity skin disease, inflammation or related symptoms on the nasolabial folds. Or with keloid (hypertrophic scar).
7. Subjects with severe cardiac, renal, hepatic, or respiratory diseases.
8. Subjects with clinically diagnosed mental illness.
9. According to American National Institute of Health standards, those who meet the criteria of Alcohol Use Disorder.
10. Subjects take immunosuppressive drugs, chemotherapy, or systemic steroids (i.e. oral or injection) within 12 weeks before screening.
11. Subjects take anticoagulant treatment or NSAIDs within 1 week before screening.
12. Subjects have permanent implants in the nasolabial folds area.
13. Subjects have nasolabial folds augment treatment such as autologous fat, hyaluronic acid or collagen filler implant within 52 weeks before screening.
14. Subjects have nasolabial fold correctional procedure or treatment such as botulinum toxin injection, chemical peeling, laser at dermis or plastic surgery.
15. Subjects unable to comply the scheduled follow-up.
16. Subjects participate other clinical trials within 12 weeks before screening (trials only with questionnaire or specimen collection are exemption).
17. Subjects who are not eligible for this trial based on the judgment of investigators.

Primary outcomes:
measure: WSRS score evaluation
timeFrame: 24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
Secondary outcomes:
measure: WSRS score evaluation within 4 time point as assessed by the evaluators
timeFrame: 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.
measure: GAIS score at specific week as assessed by the subject
timeFrame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
measure: GAIS score at specific week as assessed by the evaluators
timeFrame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
measure: VAS score evaluation
timeFrame: 30 minutes. Double-sided print or photocopy the next 2 diagrams ensuring that the lines are exactly 10 cm in length and superimposed.
measure: TPS score evaluation
timeFrame: 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.
Other outcomes:
measure: Safety Endpoint (Evaluation of laboratory inspection values.)
timeFrame: One year. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
measure: Safety Endpoint (Evaluation of the percentage of AE and AR)
timeFrame: One year. Number of participants with AE divided by number of participants with AR is the percentage of AE and AR.
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: