TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds

Exclusion Criteria

• •Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control
• •Known hypersensitivity/allergy to any component of the study devices
• •Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock
• •Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
• •Clinically significant active skin disease within 6 months
• •History of active chronic debilitating systemic disease
• •History of connective tissue disease
• •History of malignancy (excl. non-melanoma skin cancer) within past 5 years
• •History of bleeding disorders
• •Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit
• •Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery)
• •Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
• •Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas
• •A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation