Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06151535 | A Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for the Improvement of Skin Quality in Adult Participants | PHASE2 | COMPLETED | 30 | — | — | Dec 19, 2023 | Feb 24, 2025 | Mar 5, 2025 | 1 | Italy |
The ACSS is a 5-point photonumeric scale that assesses the appearance of cheek smoothness vs coarseness where 0=none and 4=extreme. A responder is a participant with at least 1-grade improvement from baseline in ACSS.
The AFLS is a 5-point photonumeric scale that assesses the appearance of fine lines where 0=none and 4=diffuse superficial lines. A responder is a participant with at least 1-grade improvement from baseline in AFLS.
| Arm | Type | Description |
|---|---|---|
| ELAPR002f Injectable Gel | EXPERIMENTAL | Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel and will be followed for 4 months. |
| Name | Type | Description |
|---|---|---|
| ELAPR002f Injectable Gel | DEVICE | Intradermal Injections |
Inclusion Criteria: * Participants in general good health, in the opinion of the investigator, with no known active COVID-19 infection, seeking improvement of facial skin quality. * Moderate or severe (symmetric grade 2 or 3 on the Allergan Fine Lines Scale \[AFLS\] and Allergan Cheek Smoothness Sc...