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

ConditionNasolabial Folds, Wrinkles
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorHyundae Meditech

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • YOUTHFILL Fine with Lidocaine

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: DIOSHA S Lido InjectionExperimental treatment 1 intervention
Group B: YOUTHFILL Fine with Lidocaine InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Nasolabial Fold Severity Score at Week 24

Time frame
Baseline to Week 24

Secondary outcomes

1

Change from Baseline in Nasolabial Fold Severity Score at Week 48

Time frame
Baseline to Week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hyundae Meditech

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: