Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles

Exclusion Criteria

• •Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
• •Previous Botox treatment to the lower two-thirds of the face within the past 6 months for subjects who will have injections into their radial cheek lines. Note: this exclusion criterion does not apply to subjects who only will have injections into lip rhytids unless the previous Botox treatment was administered within the past 6 months to the upper lip region;
• •Previous semipermanent injectable filler therapy to the mid-lower face within the past year or any prior history of permanent filler therapy injection to the mid-lower face;
• •Prior cosmetic procedures (i.e., facelift, etc.) or visible scars that may affect evaluation of response and/or quality of photography in the opinion of the investigator;
• •Known allergy or sensitivity to any of the treatment injections or their components, including known or suspected lidocaine hypersensitivity;
• •Known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies;
• •Subjects with an infection at an injection site or systemic infection (in this case, postpone study entry until one week following recovery);
• •Subjects requiring treatment with major anticoagulants (such as Coumadin) or antiplatelets (such as Plavix) during the study; low-dose aspirin treatment or antiinflammatory medication with potential anticoagulant or antiplatelet effect may be allowed at the investigator's discretion;
• •Concurrent participation in an investigational drug or device study or participation within 30 days of study start;
• •Subjects are not to undergo any additional cosmetic procedures during the study period;
• •Subjects are not to change use of any facial products up to 6 months prior to enrollment and during study period;
• •Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.