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

Launched by TEOXANE SA · Jul 17, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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