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

Nasolabial Folds Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612958
• Other study ID #: DKM-410-MD-1
• Status: Completed
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: November 2022
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 28, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• DKM-410
Injection up to 2.0ml
• Juvederm ULTRA PLUS XC 1.0ml
Injection up to 2.0ml

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.	Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.	Baseline and Week 24
Secondary	Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.	WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.	Baseline and Weeks 8, 16 and 48.
Secondary	Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.	The percentage of subjects whose WSRS score was lowered by 1 or more points.	Baseline and Weeks 8, 16, 24 and 48.
Secondary	Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.	WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.	Baseline and Weeks 8, 16, 24 and 48.
Secondary	Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.	The percentage of subjects whose WSRS score was lowered by 1 or more points.	Baseline and Weeks 8, 16, 24 and 48.
Secondary	Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.	Global Aesthetic Improvement Scale (GAIS) from -1 to 3, with grade -1 as worse, grade 0 as no change, grade 1 as improved, grade 2 as much improved, grade 3 as very much improved.	Baseline and Weeks 8, 16, 24 and 48.
Secondary	Visual Analog Scale (VAS) after the treatment.	Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain.	Baseline