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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00999141 | Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy | PHASE3 | COMPLETED | 75 | — | — | Sep 1, 2009 | Feb 1, 2010 | Oct 8, 2012 | 6 | United States |
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 4 s-apr | EXPERIMENTAL | One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Standard of Care (SoC) | NO_INTERVENTION | Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Name | Type | Description |
|---|---|---|
| FS VH S/D 4 s-apr | BIOLOGICAL | FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area. |
Inclusion Criteria: * Male or female subject is 18 to 75 years of age at the time of screening * Subject is planned for facial rhytidectomy * Subject has read, understood and signed the written informed consent * Subject is healthy, as determined by the investigator using standard pre-operative ass...