Clinical trial NCT05612958: Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds
Official title: Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Dongkook Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.
timeFrame: Baseline and Weeks 8, 16 and 48.
measure: Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.
timeFrame: Baseline and Weeks 8, 16, 24 and 48.
measure: Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.
timeFrame: Baseline and Weeks 8, 16, 24 and 48.
measure: Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.
timeFrame: Baseline and Weeks 8, 16, 24 and 48.
measure: Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.
timeFrame: Baseline and Weeks 8, 16, 24 and 48.
measure: Visual Analog Scale (VAS) after the treatment.
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References: