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

National Taiwan University

Status: Unknown

Conditions: Nasolabial Fold

Treatments: Device: Sunmax FULLSGEN with Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03844529

201809007DSA

Details and patient eligibility

About

Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Sunmax FULLSGEN with Lidocaine

Experimental group

Description:

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.

Treatment:

Device: Sunmax FULLSGEN with Lidocaine

Sumax FACIALGAIN collagen Implant with Lidocaine

Active Comparator group

Description:

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.

Treatment:

Device: Sunmax FULLSGEN with Lidocaine