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

Dongkook Pharmaceutical Co., Ltd.1 site in 1 country82 target enrollmentMarch 23, 2021

ConditionsNasolabial Folds

Overview

Phase: N/A
Intervention: Not specified
Conditions: Nasolabial Folds
Sponsor: Dongkook Pharmaceutical Co., Ltd.
Enrollment: 82
Locations: 1
Primary Endpoint: Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 23, 2021

End Date

June 28, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.

Time Frame: Baseline and Week 24

Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.

Secondary Outcomes

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.)
Visual Analog Scale (VAS) after the treatment.(Baseline)