Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds

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.

Study Overview

• Status: Unknown
• Conditions: Nasolabial Fold
• Intervention / Treatment: Device: Sunmax FULLSGEN with Lidocaine

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunmax FULLSGEN with Lidocaine; 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.	Device: Sunmax FULLSGEN 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.; Other Names: Sumax FACIALGAIN collagen Implant with Lidocaine
Active Comparator: Sumax FACIALGAIN collagen Implant with Lidocaine; 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.	Device: Sunmax FULLSGEN 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.; Other Names: Sumax FACIALGAIN collagen Implant with Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint (Evaluation of laboratory inspection values.)	Evaluation of laboratory inspection values.	One year. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Safety Endpoint (Evaluation of the percentage of AE and AR)	Evaluation of the percentage of AE and AR	One year. Number of participants with AE divided by number of participants with AR is the percentage of AE and AR.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Chang Gung Memorial Hospital; Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 201809007DSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No