NCT07032597

A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants

A Multicenter, Evaluator Blinded, Randomized Study to Evaluate the Safety and Effectiveness of HArmonyCa Lidocaine Compared to Restylane® Perlane® Lidocaine for Restoration and/or Creation of Mid-face Volume

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit. HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China. Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions

• Mid Face Volume Deficit

Interventions

Type	Name	Description
DEVICE	HArmonyCa Lidocaine Injectable Gel	Subdermal or Deep Dermal or Supraperiosteal Injection
DEVICE	Restylane® Perlane® Lidocaine	Subcutaneous to Supraperiosteal Implantation Injection

Timeline

• Start date: 2025-05-26
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-06-24
• Last updated: 2025-08-14

Locations

9 sites across 1 country: China