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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05818709 | A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants | PHASE3 | COMPLETED | 61 | — | — | Jun 14, 2023 | Dec 5, 2025 | Dec 26, 2025 | 17 | Germany, Spain |
A "responder" is a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study intervention which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study intervention.
| Arm | Type | Description |
|---|---|---|
| HAC 22L | EXPERIMENTAL | Participants will be randomized to receive HAC 22L on Day 1. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HAC 22L during the follow-up period. |
| Control Group | OTHER | Participants can opt to receive HAC 22L after a control period of 6 months. Participants will have the opportunity to receive an optional touch-up treatment and will be followed for an additional 6 months period. |
| Name | Type | Description |
|---|---|---|
| HAC 22L | DEVICE | Subcutaneous and/or Supraperiosteal injection |
Inclusion Criteria: * Participant in general good health * Seeking improvement/correction of mid-face volume * Participant has overall mid-face severity of Moderate (3), Significant (4), or Severe (5) on the 6-point photonumeric MFVDS as assessed by the EI * Participant capable of giving signed inf...