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

This is a single center, prospective, open label, randomized, comparative, split-face study
in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm®
Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip
rhytids and/or radial cheek lines.

Inclusion Criteria:

- Adult females or males, aged 25 to 70 years;

- Subjects must be seeking treatment with Juvéderm Ultra and CosmoDerm 1 injections for
vertical lip rhytids or radial cheek lines;

- Subjects must have one or more moderate to severe vertical lip rhytids and/or moderate
to severe radial cheek lines based on the physician evaluator assessment (0-3 scale);

- Women must either be of non-childbearing potential (i.e., surgically sterilized or
post-menopausal) or if of childbearing potential, must not be pregnant (as documented
by a negative urine pregnancy test at the baseline examination) or lactating and must
be practicing a medically acceptable method of birth control;

- Subjects must be willing and able to provide written informed consent;

- Subjects must be willing and able to follow the procedures outlined in this protocol.

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.