Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
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
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
February 17, 2026
February 1, 2026
11 months
February 9, 2026
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Nasolabial Fold Severity Score at Week 24
Baseline to Week 24
Secondary Outcomes (1)
Change from Baseline in Nasolabial Fold Severity Score at Week 48
Baseline to Week 48
Study Arms (2)
DIOSHA S Lido Injection
EXPERIMENTALYOUTHFILL Fine with Lidocaine Injection
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hyundae Meditechlead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02