DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
This study is being undertaken to:

 -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic
 acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment
 of dermal nasolabial fold wrinkles at 13 months following the last application of study
 treatment.

 -  Document the types and incidence of adverse events reported with DL6049 (injectable
 poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events
 will be assessed for an additional 12 months following discharge from the main study in
 subjects treated with DL6049.
Inclusion Criteria:

 -  Subjects must sign a statement of IC and HIPAA authorization. In addition subjects
 must provide a separate release for use of their photographs in publications; any
 subject has a right to refuse the photo release without jeopardizing their ability to
 participate in the study.

 -  Subjects must be 18-75 yrs of age, of any race or sex

 -  Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy;
 or have a had a tubal ligation; or if of child-bearing potential, must agree to use an
 approved method of birth control throughout the study (i.e, oral/systemic
 contraceptives, IUD, or spermicide in combination with barrier method of
 contraception).

 -  Subjects seeking augmentation therapy for bilateral correction of nasolabial folds.
 Subjects must have a score of greater than or equal to 2 and less than or equal to 4
 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of
 both the left and right nasolabial fold at Visit 1.

 Exclusion Criteria:

 -  Subjects with a personal history of allergic/anaphylactic reactions including
 hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex,
 silicone, carmellose, or mannitol.

 -  Subjects with a known history of keloids or bleeding disorders.

 -  Subjects with an active inflammatory process in the area to be treated (skin eruptions
 such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active
 skin disease).

 -  Subjects with active hepatitis within the past year.

 -  Subjects who are pregnant (confirmation by pregnancy testing),or plan to become
 pregnant within the study timeframe, or who are nursing.

 -  Subjects who plan to undergo major facial surgery (e.g., rhinoplasty with or without
 implant, facelift, congenital defect repair, etc. during the course of the study.

 -  Subjects with clinically important disease as judged by the investigator within 3
 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke,
 cancer, connective tissue diseases, etc.) including subjects with medical conditions
 that might require the use of immunosuppressive medications during the trial (e.g.,
 severe asthma, rheumatoid arthritis, etc.).

 -  Subjects who have used exclusionary medications/treatments.