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NCT Number: NCT07412392

Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds

Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds

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Key information

Conditions

Nasolabial Folds, Wrinkles

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 19 to 75 years
  • Voluntarily provided written informed consent
  • Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 on both sides)
  • Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
  • Able to understand instructions and comply with study procedures

Exclusion criteria

  • Active facial skin disease, infection, or untreated scars in the treatment area
  • History of severe allergy or hypersensitivity to device components
  • Facial aesthetic or invasive procedures in the treatment area within 6 months prior to screening
  • Use of prohibited medications within required washout periods
  • Participation in another interventional clinical trial within 4 weeks prior to screening or during the study
  • Pregnancy, breastfeeding, or non-compliance with contraception requirements
  • Any condition deemed inappropriate by the investigator

Treatment and study plan

DIOSHA S Lido

Device

Injection of a hyaluronic acid dermal filler containing lidocaine into the nasolabial folds for the temporary correction of moderate to severe nasolabial folds. Treatment is administered according to the study protocol, and participants are followed through Week 48 for efficacy and safety assessments.

YOUTHFILL Fine with Lidocaine

Device

Injection of a hyaluronic acid dermal filler containing lidocaine into the nasolabial folds for the temporary correction of moderate to severe nasolabial folds. Treatment is administered according to the study protocol, and participants are followed through Week 48 for efficacy and safety assessments.

Primary outcomes

  1. Change from Baseline in Nasolabial Fold Severity Score at Week 24

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Change from Baseline in Nasolabial Fold Severity Score at Week 48

    Time frame: Baseline to Week 48

Sponsors and collaborators

Lead sponsor

Hyundae Meditech

Industry

Registry information

Official study title

A Multi Center, Randomized, Subject & Independent Evaluator-blinded, Matched Pairs, Active Controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With DIOSHA S Lido as Compared to YOUTHFILL(YOUTHFILL Fine With Lidocaine) in Temporary Correction of Moderate to Severe Nasolabial Folds

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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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