Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DIOSHA S Lido, YOUTHFILL Fine with Lidocaine.
- Who it may be relevant to
- Registry conditions: Nasolabial Folds, Wrinkles. Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Interventions
- 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. - 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.
Primary outcome measures
- Change from Baseline in Nasolabial Fold Severity Score at Week 24 [Time frame: Baseline to Week 24]
Secondary outcome measures (1)
- Change from Baseline in Nasolabial Fold Severity Score at Week 48 [Time frame: Baseline to Week 48]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07412392 · HD-CIP-001