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

A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA Global Action and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC in the Treatment of Moderate to Severe Nasolabial Folds

The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.

Inclusion Criteria:

• Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception
• NLFs classified as WSRS grade 3 or 4 (same score for each side)
• Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
• Able to follow study instructions and likely to complete all required visits;
• Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form

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