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

NCT03844529 | Unknown DMC

• 1 other identifier: 201809007DSA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• WSRS score evaluation within 4 time point 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

  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

  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

  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

  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 (2)

• Safety Endpoint (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)

  One year. Number of participants with AE divided by number of participants with AR is the percentage of AE and AR.

Study Arms (2)

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.

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.

Device: Sunmax FULLSGEN with Lidocaine

Interventions

Sunmax FULLSGEN with Lidocaine DEVICE

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.

Also known as: Sumax FACIALGAIN collagen Implant with Lidocaine

Sumax FACIALGAIN collagen Implant with Lidocaine; Sunmax FULLSGEN with Lidocaine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Tri-Service General Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double blinded( blinded evaluator and subject) clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 240 subjects will be recruited in total, and each hospital will recruit 60\~120 subjects.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 18, 2019
• Study Start: March 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: August 31, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)