Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds : Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- & evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory designTreatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)Population: Number of subject 100* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design)..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 15. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 12, 2024, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 |
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| Study ID: |
NCT06305520 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000056456 |
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| 245 | 1 | 0 | |a Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds |b Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 12, 2024, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 | ||
| 520 | |a Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- & evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory designTreatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)Population: Number of subject 100* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). | ||
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