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

NCT ID: NCT05612958

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2022-06-28

Brief Summary

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.

Conditions

Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DKM-410

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

Group Type: EXPERIMENTAL

DKM-410

Intervention Type: DEVICE

Injection up to 2.0ml

Juvederm ULTRA PLUS XC 1.0ml

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

Group Type: ACTIVE_COMPARATOR

Juvederm ULTRA PLUS XC 1.0ml

Intervention Type: DEVICE

Injection up to 2.0ml

Interventions

DKM-410

Injection up to 2.0ml

Intervention Type: DEVICE

Juvederm ULTRA PLUS XC 1.0ml

Injection up to 2.0ml

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongkook Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DKM-410-MD-1

Identifier Type: -

Identifier Source: org_study_id