Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305520
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-15
First Post:
2024-03-01
Brief Title:
Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds
Sponsor:
Bioplus
Organization:
Bioplus
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPLUS-02
Brief Summary:
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 design
Treatment 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
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 design
Treatment 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRIS NO KCT0008113 | REGISTRY | The Clinical Research Information Service CRIS in KOREA | None |