A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants
← catalyst calendarNCT07032597 · readout ≤ 12 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
252actual
Sites
9
Country
China
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-26 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mid Face Volume Deficit
Interventions
- Device: HArmonyCa Lidocaine Injectable Gel
- Device: Restylane® Perlane® Lidocaine
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
measured Month 6
Number of Participants with Adverse Events (AEs)
measured Up to Approximately Month 14
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