NCT05818709

A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants

A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Study of the Safety and Effectiveness of HAC 22L for Improving Midface Volume

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Chronic reduction in any one of these components as well as a loss of muscle and fat mass contribute to the facial volume loss that characterizes the aging face. HAC 22L is a dermal filler administered via subcutaneous/supraperiosteal injection for volumizing effect. The purpose of the study is to assess adverse events and effectiveness of HAC 22L in adults with facial volume deficit. HAC 22L is a novel injectable device being developed to improve mid-face volume. 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 control group. Around 75 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 20 sites worldwide. Participants in the treatment group will receive HAC 22L injection at Day 1. Participants will have the opportunity to receive optional touch-up and will be followed for up to 24 months. An optional repeat treatment will be offered after the follow-up period. Participants in the control group will followed for 6 months (no treatment period). At completion of the control period, participants may exit or opt to receive the study treatment (inclusive of optional touch-up). Participants will then be followed for 6 months. No repeat treatment is offered to the control group. 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 or clinic. The effect of the treatment will be checked by different methods such as medical assessments, questionnaires and instrument's measures.

Conditions

• Facial Volume Deficit

Interventions

Type	Name	Description
DEVICE	HAC 22L	Subcutaneous and/or Supraperiosteal injection

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2023-04-19
• Last updated: 2025-12-26

Locations

17 sites across 2 countries: Germany, Spain