Nasolabial Folds, WrinklesNCT07412392
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
A study testing DIOSHA S Lido and YOUTHFILL Fine with Lidocaine in people with Nasolabial Folds, Wrinkles, run by Hyundae Meditech.
Trial summary
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds, Wrinkles
- What is being tested?
- DIOSHA S Lido and YOUTHFILL Fine with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- DIOSHA S Lido, YOUTHFILL Fine with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIOSHA S LidoDevice
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 LidocaineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DIOSHA S Lido Injection | Experimental | Not described Receives: Device: DIOSHA S Lido |
| YOUTHFILL Fine with Lidocaine Injection | Active comparator | Not described Receives: Device: YOUTHFILL Fine with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Nasolabial Fold Severity Score at Week 24
Measured: Baseline to Week 24
Secondary outcomes (1)
Change from Baseline in Nasolabial Fold Severity Score at Week 48
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start27 Feb 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Folds, WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundae Meditech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412392
- Sponsor's protocol ID
- HD-CIP-001
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07412392
- Acronym / sponsor ID
- HD-CIP-001
- Conditions
- Nasolabial Folds, Wrinkles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hyundae MeditechIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIOSHA S Lido Injection | Experimental | Device: DIOSHA S Lido |
| YOUTHFILL Fine with Lidocaine Injection | Active comparator | Device: YOUTHFILL Fine with Lidocaine |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIOSHA S LidoInjection 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. | Device | DIOSHA S Lido Injection |
| YOUTHFILL Fine with LidocaineInjection 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. | Device | YOUTHFILL Fine with Lidocaine Injection |
Primary outcome
Change from Baseline in Nasolabial Fold Severity Score at Week 24
Time frame: Baseline to Week 24
1 secondary outcome
Change from Baseline in Nasolabial Fold Severity Score at Week 48
Time frame: Baseline to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DIOSHA S Lido and YOUTHFILL Fine with Lidocaine in people with Nasolabial Folds, Wrinkles, run by Hyundae Meditech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Nasolabial Fold Severity Score at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.