Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds

Dongkook Pharmaceutical

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: DKM-410; Device: Juvederm ULTRA PLUS XC 1.0ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT05612958

DKM-410-MD-1

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.

Enrollment: 82 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 19 years and older
2. Wrinkle Severity Rating Scale (WSRS) 3 or 4
3. Visually symmetrical bilateral nasolabial folds
4. Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
5. Voluntarily decided to participate in the study and signed the informed consent form
6. Willing to follow the protocol

Exclusion criteria

1. History of undergoing a permanent or semi-permanent filler treatment on the face
2. Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
3. Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
4. History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
5. Hypersensitivity to Lidocaine or amide local anesthetic
6. Positive for the intradermal response test
7. History of severe or plurality of allergies
8. Having skin inflammation or infection in nasolabial folds
9. History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
10. History of streptococcal disease
11. Uncontrolled epilepsy
12. Porphyria
13. Having or being currently suffering from autoimmune diseases
14. History of immunodeficiency or immunosuppressive drugs
15. History of herpetic eruption
16. Having bleeding disorder or blood clotting disorder
17. Having anticoagulant drugs or components within 72 hours from the application of medical advice
18. Received antiplatelet drugs within 2 weeks from the application of medical advice
19. Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice
20. Received drugs that inhibit or decrease liver metabolism
21. Clinically significant abnormalities on electrocardiogram
22. Pregnant or breast-feeding or who planning to conceive
23. Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
24. Other investigational products or procedures within 3 months from screening
25. Not eligible due to other reasons at the investigator's discretion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

DKM-410

Experimental group

Description:

Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline

Treatment:

Device: DKM-410

Juvederm ULTRA PLUS XC 1.0ml

Active Comparator group

Description:

Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline

Treatment:

Device: Juvederm ULTRA PLUS XC 1.0ml