Status:
UNKNOWN
Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Tri-Service General Hospital
Chang Gung Memorial Hospital
Conditions:
Nasolabial Fold
Eligibility:
All Genders
20-65 years
Phase:
NA
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 ChangG...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03844529
Start Date
March 1 2019
End Date
August 31 2020
Last Update
March 18 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan