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OpenTrials
Completed

NCT Number: NCT05612958

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

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.

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Key information

Conditions

Nasolabial Folds

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Uncontrolled epilepsy
  • Porphyria
  • Having or being currently suffering from autoimmune diseases
  • History of immunodeficiency or immunosuppressive drugs
  • History of herpetic eruption
  • Having bleeding disorder or blood clotting disorder
  • Having anticoagulant drugs or components within 72 hours from the application of medical advice
  • Received antiplatelet drugs within 2 weeks from the application of medical advice
  • 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
  • Received drugs that inhibit or decrease liver metabolism
  • Clinically significant abnormalities on electrocardiogram
  • Pregnant or breast-feeding or who planning to conceive
  • Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
  • Other investigational products or procedures within 3 months from screening
  • Not eligible due to other reasons at the investigator's discretion

Treatment and study plan

DKM-410

Device

Injection up to 2.0ml

Juvederm ULTRA PLUS XC 1.0ml

Device

Injection up to 2.0ml

Primary outcomes

  1. 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

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Weeks 8, 16, 24 and 48.

    The percentage of subjects whose WSRS score was lowered by 1 or more points.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Weeks 8, 16, 24 and 48.

    The percentage of subjects whose WSRS score was lowered by 1 or more points.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline

    Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain.

Sponsors and collaborators

Lead sponsor

Dongkook Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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