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

NCT05612958 | Completed

• 1 other identifier: DKM-410-MD-1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.

  Baseline and Weeks 8, 16 and 48.

• Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.

  Baseline and Weeks 8, 16, 24 and 48.

• Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.

  Baseline and Weeks 8, 16, 24 and 48.

• Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.

  Baseline and Weeks 8, 16, 24 and 48.

• Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.

  Baseline and Weeks 8, 16, 24 and 48.

Study Arms (2)

DKM-410

EXPERIMENTAL

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

Device: DKM-410

Juvederm ULTRA PLUS XC 1.0ml

ACTIVE COMPARATOR

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

Device: Juvederm ULTRA PLUS XC 1.0ml

Interventions

DKM-410 DEVICE

Injection up to 2.0ml

DKM-410

Juvederm ULTRA PLUS XC 1.0ml DEVICE

Injection up to 2.0ml

Juvederm ULTRA PLUS XC 1.0ml

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of undergoing a permanent or semi-permanent filler treatment on the face
• Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
• Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
• History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
• Hypersensitivity to Lidocaine or amide local anesthetic
• Positive for the intradermal response test
• History of severe or plurality of allergies
• Having skin inflammation or infection in nasolabial folds
• History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
• History of streptococcal disease
• Uncontrolled epilepsy
• Porphyria
• Having or being currently suffering from autoimmune diseases
• History of immunodeficiency or immunosuppressive drugs
• History of herpetic eruption

Sponsors & Collaborators

• Dongkook Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 10, 2022
• Study Start: March 23, 2021
• Primary Completion: January 14, 2022
• Study Completion: June 28, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

KR (1)