A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour...

Area of Science:

• Dermatology
• Aesthetic Medicine
• Plastic Surgery

Background:

• HARC is a flexible hyaluronic acid filler utilizing XpresHAn technology for natural-looking volume restoration.
• It is formulated with lidocaine for patient comfort during aesthetic procedures.

Purpose of the Study:

• To assess the safety and effectiveness of HARC for cheek augmentation and midface contour correction.
• The primary goal was to establish non-inferiority of HARC compared to a control hyaluronic acid filler (HAJV) in improving midface fullness.

Main Methods:

• A randomized controlled trial involving 210 subjects (142 HARC, 68 Control) with midface volume loss.
• Participants were assessed using the Midface Volume Measurement Scale (MMVS) and evaluated for aesthetic improvement and satisfaction over 48 weeks.

Main Results:

• HARC was found to be non-inferior to the control, with similar mean changes in MMVS scores at 12 weeks.
• High levels of aesthetic improvement and subject satisfaction were observed with HARC throughout the 48-week study period.
• Adverse events associated with HARC were predominantly mild and transient.

Conclusions:

• HARC is a well-tolerated hyaluronic acid filler that is non-inferior to a control for midface augmentation.
• The filler provides significant aesthetic improvement and high patient satisfaction, with effects sustained up to 48 weeks post-injection.