Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HAC 22L · 1 trial · 1 indication
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...
HAC 22L is an investigational injectable treatment for facial volume deficit, specifically for mid-face volume in adults. It is being developed for use in dermatology to address age-related volume loss in the face. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
HAC 22L is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the safety and effectiveness of HAC 22L for facial volume deficit in adult participants.
HAC 22L is in Phase 3 clinical development. A Phase 3 study has been completed to assess adverse events and effectiveness of HAC 22L injection for mid-face volume in adult participants. The drug remains investigational and has not received FDA approval.
HAC 22L has one completed Phase 3 clinical trial registered as NCT05818709. This study assessed adverse events and effectiveness of HAC 22L injection for mid-face volume in adults, enrolling 61 participants across Germany and Spain. The trial was controlled but not double-blinded.
No alternative names for HAC 22L have been reported. The drug is identified solely as HAC 22L in clinical trial registrations and development documentation. It is an investigational product being studied specifically for facial volume deficit.