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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05452070 | A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation in Adult Participants | PHASE3 | COMPLETED | 171 | — | — | Sep 2, 2022 | May 8, 2025 | Jun 1, 2026 | 12 | Canada, Spain +1 |
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. ...