TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults

Inclusion criteria

• Chinese male and female, 18 years of age or older.
• Subject seeking treatment of moderate to severe tissue volume deficiencies in the infraorbital region.
• Subjects with a grade of 2 (moderate) or 3 (severe) on the TIOHS for both eyes, as determined on assessments by the Treating Investigator (TI) and BLE.
• Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, Intense Pulsed Light [IPL], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
• Woman of childbearing potential agree to use contraception during the investigation.
• Subject understands and is able to follow instructions and complete all scheduled visits.
• Subjects who voluntarily decided to participate in the investigation and signed the informed consent.

Exclusion criteria

• Known hypersensitivity or previous allergic reaction to any component of the study device.
• Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• History of connective tissue disease.
• Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
• Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.