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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07412392
Enrollment
60
Registered
2026-02-17
Start date
2026-02-27
Completion date
2027-07-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Folds, Wrinkles

Brief summary

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

Interventions

DEVICEDIOSHA S Lido

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.

DEVICEYOUTHFILL Fine with Lidocaine

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.

Sponsors

Hyundae Meditech
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Nasolabial Fold Severity Score at Week 24Baseline to Week 24

Secondary

MeasureTime frame
Change from Baseline in Nasolabial Fold Severity Score at Week 48Baseline to Week 48

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026