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

February 9, 2026 updated by: Hyundae Meditech

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DIOSHA S Lido Injection
Device: DIOSHA 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.
Active Comparator: YOUTHFILL Fine with Lidocaine Injection
Device: YOUTHFILL 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyundae Meditech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 27, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HD-CIP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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