Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With... | NCT07412392

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

NCT07412392

Sponsor

Hyundae Meditech

Status

Not yet recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Nasolabial Folds, Wrinkles

Interventions

DIOSHA S Lido
YOUTHFILL Fine with Lidocaine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official 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

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2026Estimated

Primary Completion Date

Jan 30, 2027Estimated

Completion Date

Jul 30, 2027Estimated

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 9, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DIOSHA S Lido Injection	Experimental		Device: DIOSHA S Lido
YOUTHFILL Fine with Lidocaine Injection	Active Comparator		Device: YOUTHFILL Fine with Lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Nasolabial Fold Severity Score at Week 24		Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Nasolabial Fold Severity Score at Week 48		Baseline to Week 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided