Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HArmonyCa Lidocaine Injectable · 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 pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
| Arm | Type | Description |
|---|---|---|
| HArmonyCa Lidocaine Injectable Gel | EXPERIMENTAL | Participants will receive HArmonyCa Lidocaine Injectable Gel on Day 1 and followed for up to 25 months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period. |
| Control Group | OTHER | Participants will be followed for 3 months. Participants can opt to receive HArmonyCa Lidocaine Injectable Gel after 3 months and followed for up to 25 months. |
| Name | Type | Description |
|---|---|---|
| HArmonyCa Lidocaine Injectable Gel | DEVICE | Subdermal or deep dermal injection |
Inclusion Criteria: * Participant must be in general good health. * Participant seeking soft tissue augmentation in the mid face. * Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. ...
HArmonyCa Lidocaine Injectable is an investigational injectable gel studied for mid face soft tissue augmentation in adult participants with mid face volume deficit. It is being developed by AbbVie Inc. and is currently in Phase 3 clinical development.
HArmonyCa Lidocaine Injectable is designed for mid face soft tissue augmentation, addressing mid face volume deficit. The specific molecular target or mechanism of action has not been disclosed in available information.
HArmonyCa Lidocaine Injectable is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
HArmonyCa Lidocaine Injectable is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
HArmonyCa Lidocaine Injectable was studied in a completed Phase 3 trial, NCT05452070, which assessed adverse events and change in disease activity for mid face soft tissue augmentation in 171 adult participants across Canada, Spain, and the United Kingdom.
HArmonyCa Lidocaine Injectable is a formulation that includes lidocaine, an anesthetic, combined with the HArmonyCa gel. The trial NCT05452070 specifically evaluated this lidocaine-containing version for mid face volume deficit.